Payroll Officer - Lisburn - £30,000 + Excellent benefits Cpl NI are pleased to work with a leading manufacturing company that has grown significantly over the past 40 years. They are looking for a driven, highly organised Payroll Officer to assist with the delivery and processing of multiple high-volume payrolls. You'll play a key role in ensuring payroll is accurate, compliant, and delivered on time. Benefits: Bonus Scheme Enhanced Annual Leave Loyalty Bonus Personal And Professional Development Flexitime Death In Service Employee Referral Scheme Family Friendly Policy Health Shield And more! Duties: Process and approve weekly and monthly payrolls. Handle payroll queries and provide timely resolutions. Manage statutory payments (SSP, SMP, SPP) and pension obligations, including auto-enrolment. Coordinate with HR on new starters, leavers, leave entitlements, and life cycle administration. Maintain payroll records, reports, and headcount data. Liaise with third-party providers, auditors, and insurers. Ensure compliance with payroll legislation and update SOPs. Support annual tasks such as salary reviews, benefits renewals, and P11D submissions. Criteria: Minimum of 2 years of experience in a payroll function. Strong payroll processing experience, ideally in high-volume environments. Knowledge of payroll legislation and compliance. Excellent attention to detail and organisational skills. Strong communication skills and ability to work to deadlines. For more information on this position or to be considered, apply here or contact Sophie Keogh at Cpl NI.
Aug 20, 2025
Full time
Payroll Officer - Lisburn - £30,000 + Excellent benefits Cpl NI are pleased to work with a leading manufacturing company that has grown significantly over the past 40 years. They are looking for a driven, highly organised Payroll Officer to assist with the delivery and processing of multiple high-volume payrolls. You'll play a key role in ensuring payroll is accurate, compliant, and delivered on time. Benefits: Bonus Scheme Enhanced Annual Leave Loyalty Bonus Personal And Professional Development Flexitime Death In Service Employee Referral Scheme Family Friendly Policy Health Shield And more! Duties: Process and approve weekly and monthly payrolls. Handle payroll queries and provide timely resolutions. Manage statutory payments (SSP, SMP, SPP) and pension obligations, including auto-enrolment. Coordinate with HR on new starters, leavers, leave entitlements, and life cycle administration. Maintain payroll records, reports, and headcount data. Liaise with third-party providers, auditors, and insurers. Ensure compliance with payroll legislation and update SOPs. Support annual tasks such as salary reviews, benefits renewals, and P11D submissions. Criteria: Minimum of 2 years of experience in a payroll function. Strong payroll processing experience, ideally in high-volume environments. Knowledge of payroll legislation and compliance. Excellent attention to detail and organisational skills. Strong communication skills and ability to work to deadlines. For more information on this position or to be considered, apply here or contact Sophie Keogh at Cpl NI.
Cpl Life Sciences is currently partnering with a leading biotechnology company based in Central London to recruit a QC Validation Manager on a 12-month fixed-term contract. This is an exciting opportunity to play a key role in ensuring the quality and compliance of analytical test methods used in manufacturing processes. The successful candidate will oversee the full lifecycle management of analytical equipment and materials, driving method validation and qualification activities in line with regulatory standards. Key Responsibilities: Lead the validation and development of analytical test methods. Act as Subject Matter Expert (SME) for lifecycle management of assays, equipment, and materials. Prepare and review qualification and validation documentation. Ensure departmental adherence to regulatory and compliance requirements, including GMP and GDP. Manage the implementation and project lifecycle of new test methods. Collaborate with internal and external stakeholders to support testing and validation needs. Deliver training and development initiatives across the quality control team. Maintain and improve the Quality Management System (QMS). Monitor and report on Key Performance Indicators (KPIs). Provide support on CAPAs, change controls, and audit-related actions. Candidate Requirements: Degree or equivalent experience in a relevant scientific field (e.g. pharmaceuticals, biologics, or biotechnology). Proven experience in a QC validation role within a regulated environment. Strong project management and team leadership skills. Demonstrated ability to work independently and deliver results efficiently. Excellent understanding of EU and FDA regulations and industry standards (GMP, GLP, GCP). Proficient in Microsoft Office and other relevant IT systems.
Aug 18, 2025
Full time
Cpl Life Sciences is currently partnering with a leading biotechnology company based in Central London to recruit a QC Validation Manager on a 12-month fixed-term contract. This is an exciting opportunity to play a key role in ensuring the quality and compliance of analytical test methods used in manufacturing processes. The successful candidate will oversee the full lifecycle management of analytical equipment and materials, driving method validation and qualification activities in line with regulatory standards. Key Responsibilities: Lead the validation and development of analytical test methods. Act as Subject Matter Expert (SME) for lifecycle management of assays, equipment, and materials. Prepare and review qualification and validation documentation. Ensure departmental adherence to regulatory and compliance requirements, including GMP and GDP. Manage the implementation and project lifecycle of new test methods. Collaborate with internal and external stakeholders to support testing and validation needs. Deliver training and development initiatives across the quality control team. Maintain and improve the Quality Management System (QMS). Monitor and report on Key Performance Indicators (KPIs). Provide support on CAPAs, change controls, and audit-related actions. Candidate Requirements: Degree or equivalent experience in a relevant scientific field (e.g. pharmaceuticals, biologics, or biotechnology). Proven experience in a QC validation role within a regulated environment. Strong project management and team leadership skills. Demonstrated ability to work independently and deliver results efficiently. Excellent understanding of EU and FDA regulations and industry standards (GMP, GLP, GCP). Proficient in Microsoft Office and other relevant IT systems.
Financial Controller - Rapidly Growing Pharmaceutical Start-Up Job Type: Interim Location: London Salary: £50,000-£55,000 An outstanding opportunity at a small pharmaceutical start up. This client has strong external funding and incredible products coming to market. This is an ideal time to join the business as they look to accelerate growth significantly over the next few years. Please note the offer includes share options. Role Summary • Production of high-quality management and board packs for internal and external stakeholders • Handle cash flow management / projections • Run and develop a small finance team • Day to day accounting and payroll using Xero • Overhaul the financial controls, management accounts and finance processes to make sure there are solid foundations for the company's expected growth trajectory. • Finalise changeover of systems from Xero from QuickBooks • Work with a high level of accuracy and meet strict deadlines in a fast paced and dynamic environment • Willingness to roll your sleeves up, be willing to assist with things from liaising with banks and auditors to making the tea Experience required: • Qualified Accountant with experience gained working within a small but rapidly growing organisation. • Excellent communication skills: ability to deal with external providers of funding, auditors, banks through to non-Finance professionals within the business • Experience working in an organisation that has been through a period of significant change and growth • An interest in business/commercial development of an organisation • Previous involvement with private equity / venture capital backed companies would be beneficial as would experience of a company that has been through a trade sale
Aug 18, 2025
Full time
Financial Controller - Rapidly Growing Pharmaceutical Start-Up Job Type: Interim Location: London Salary: £50,000-£55,000 An outstanding opportunity at a small pharmaceutical start up. This client has strong external funding and incredible products coming to market. This is an ideal time to join the business as they look to accelerate growth significantly over the next few years. Please note the offer includes share options. Role Summary • Production of high-quality management and board packs for internal and external stakeholders • Handle cash flow management / projections • Run and develop a small finance team • Day to day accounting and payroll using Xero • Overhaul the financial controls, management accounts and finance processes to make sure there are solid foundations for the company's expected growth trajectory. • Finalise changeover of systems from Xero from QuickBooks • Work with a high level of accuracy and meet strict deadlines in a fast paced and dynamic environment • Willingness to roll your sleeves up, be willing to assist with things from liaising with banks and auditors to making the tea Experience required: • Qualified Accountant with experience gained working within a small but rapidly growing organisation. • Excellent communication skills: ability to deal with external providers of funding, auditors, banks through to non-Finance professionals within the business • Experience working in an organisation that has been through a period of significant change and growth • An interest in business/commercial development of an organisation • Previous involvement with private equity / venture capital backed companies would be beneficial as would experience of a company that has been through a trade sale
Position: Product Owner Reporting to: Head of Product - EUX Location: York, Colchester or London Type: Contract In IT Services, our collective goal is to deliver and maintain best-in-class, innovative infrastructure solutions that are sustainable, resilient and inclusive. We do this by understanding the needs of our company colleagues so that we can create and tailor the tools and services that enable them to deliver on their goals. And this increases our competitive advantage in market. We work within an Agile methodology, because that helps us to deliver the right solutions quickly and accurately. It also means that we have the flexibility to pivot and adapt our work, through iterative testing with our company colleagues. We communicate and collaborate effectively with each other every day. This ensures that each of us knows what we need to achieve. And we take individual and team accountability for ensuring that everything we deliver brings value to our business. We're driven to innovate through technology, we're valued for our skills, our work is varied, and we're encouraged to take every opportunity to develop and grow. In IT Services, we set you up to succeed, the rest is up to you. The Product Owner role We're looking for a Product Owner (PO) to join our IT Services team, working within our End User Compute value stream to drive the development and improvement of our products. This is an extremely varied role and will include (but is not limited to) the following activities: Develop and execute the end user compute product roadmap, ensuring alignment with the value stream OKRs. Conduct workshops and analysis activities to design and define appropriate delivery iterations - gather requirements, assess value, ensure work is prioritised and focused on delivering maximum value for our colleagues. Write clear and concise user stories, acceptance criteria and product specifications. Prioritise and manage the product backlog, ensuring it is maintained and refined. Work with the Agile Delivery Lead/s (ADLs) to ensure there is a steady flow of work for the squad/s aligned to the product roadmap. Create and own dashboards to track metrics, utilise the data to inform future backlog items that target waste and inefficiency. Be the first point of contact for the squad/s to answer any product related questions, clarify requirements and support the ADL to remove blockers. Act as the voice of the customer to ensure everyone understands the business value of the backlog items. Working with the ADL to coordinate and participate all Agile ceremonies for the product - stand-ups, refinement, planning and retrospectives. Provide feedback on the product roadmap, resolving risks, issues and blockers raised by the squad/s - escalating to the Head of Product as needed. Report on actual vs. expected progress and any knock-on impact to the product roadmap. Manage key stakeholder relationships and communicate effectively to keep them informed. Monitor and analyse product performance, identifying areas for improvement and making data-driven decisions. Coordinate product launches, ensuring effective communication to internal customers and stakeholders. Stay up-to-date with industry best practices and trends in product management, technology and user experience. Work with the other members of the ITS Product Chapter to share knowledge, best practices and develop as a team - as a Product Owner, you will coach, and mentor Associate POs to support their career development. Actively participate in the wider product management community to aid continuous learning, innovation, best practice and alignment with the companies engineering teams. Required skills/experience Prior experience in a product-related role or environment - working in Agile delivery teams, managing a backlog to ensure business value is prioritised, delivered and embedded. Knowledge of implementing and managing End User Experience technologies and tools is essential; e.g., Win 11, desktops, M365, printing, telephony, collaboration tools etc. An aptitude for customer centric problem solving and challenging the status quo. Experience working with Agile collaboration (e.g. Jira, Confluence, etc.) and product management tools. Experience of writing business requirements that can be picked up by engineers and implemented. Highly organised, detail-oriented with a focus on quality and delivering value to customers. Excellent written and verbal communication skills, with the ability to effectively convey complex ideas to both technical and non-technical stakeholders. Ability to work collaboratively in a fast-paced environment and adapt to changing priorities (dealing with any associated conflict due to competing priorities). Demonstrable analytical and problem-solving skills, with the ability to gather and interpret data to make informed decisions. Beneficial experience Demonstrable experience of 'lean thinking' - continuously looking to minimise waste and drive efficiency. Detailed understanding of Agile methodologies (Kanban, Lean, Scrum) and product management frameworks. Relevant qualifications (e.g. Certified Scrum Product Owner).
Aug 16, 2025
Full time
Position: Product Owner Reporting to: Head of Product - EUX Location: York, Colchester or London Type: Contract In IT Services, our collective goal is to deliver and maintain best-in-class, innovative infrastructure solutions that are sustainable, resilient and inclusive. We do this by understanding the needs of our company colleagues so that we can create and tailor the tools and services that enable them to deliver on their goals. And this increases our competitive advantage in market. We work within an Agile methodology, because that helps us to deliver the right solutions quickly and accurately. It also means that we have the flexibility to pivot and adapt our work, through iterative testing with our company colleagues. We communicate and collaborate effectively with each other every day. This ensures that each of us knows what we need to achieve. And we take individual and team accountability for ensuring that everything we deliver brings value to our business. We're driven to innovate through technology, we're valued for our skills, our work is varied, and we're encouraged to take every opportunity to develop and grow. In IT Services, we set you up to succeed, the rest is up to you. The Product Owner role We're looking for a Product Owner (PO) to join our IT Services team, working within our End User Compute value stream to drive the development and improvement of our products. This is an extremely varied role and will include (but is not limited to) the following activities: Develop and execute the end user compute product roadmap, ensuring alignment with the value stream OKRs. Conduct workshops and analysis activities to design and define appropriate delivery iterations - gather requirements, assess value, ensure work is prioritised and focused on delivering maximum value for our colleagues. Write clear and concise user stories, acceptance criteria and product specifications. Prioritise and manage the product backlog, ensuring it is maintained and refined. Work with the Agile Delivery Lead/s (ADLs) to ensure there is a steady flow of work for the squad/s aligned to the product roadmap. Create and own dashboards to track metrics, utilise the data to inform future backlog items that target waste and inefficiency. Be the first point of contact for the squad/s to answer any product related questions, clarify requirements and support the ADL to remove blockers. Act as the voice of the customer to ensure everyone understands the business value of the backlog items. Working with the ADL to coordinate and participate all Agile ceremonies for the product - stand-ups, refinement, planning and retrospectives. Provide feedback on the product roadmap, resolving risks, issues and blockers raised by the squad/s - escalating to the Head of Product as needed. Report on actual vs. expected progress and any knock-on impact to the product roadmap. Manage key stakeholder relationships and communicate effectively to keep them informed. Monitor and analyse product performance, identifying areas for improvement and making data-driven decisions. Coordinate product launches, ensuring effective communication to internal customers and stakeholders. Stay up-to-date with industry best practices and trends in product management, technology and user experience. Work with the other members of the ITS Product Chapter to share knowledge, best practices and develop as a team - as a Product Owner, you will coach, and mentor Associate POs to support their career development. Actively participate in the wider product management community to aid continuous learning, innovation, best practice and alignment with the companies engineering teams. Required skills/experience Prior experience in a product-related role or environment - working in Agile delivery teams, managing a backlog to ensure business value is prioritised, delivered and embedded. Knowledge of implementing and managing End User Experience technologies and tools is essential; e.g., Win 11, desktops, M365, printing, telephony, collaboration tools etc. An aptitude for customer centric problem solving and challenging the status quo. Experience working with Agile collaboration (e.g. Jira, Confluence, etc.) and product management tools. Experience of writing business requirements that can be picked up by engineers and implemented. Highly organised, detail-oriented with a focus on quality and delivering value to customers. Excellent written and verbal communication skills, with the ability to effectively convey complex ideas to both technical and non-technical stakeholders. Ability to work collaboratively in a fast-paced environment and adapt to changing priorities (dealing with any associated conflict due to competing priorities). Demonstrable analytical and problem-solving skills, with the ability to gather and interpret data to make informed decisions. Beneficial experience Demonstrable experience of 'lean thinking' - continuously looking to minimise waste and drive efficiency. Detailed understanding of Agile methodologies (Kanban, Lean, Scrum) and product management frameworks. Relevant qualifications (e.g. Certified Scrum Product Owner).
Job Title: Senior Microbiology Team Lead Location: Oxford Pay rate: £50 per hour 12 month contract Cpl Life Sciences is working exclusively with a biotech company seeking a Senior Microbiology Team Lead to oversee and drive microbiological research, method development, and regulatory compliance. This leadership role involves managing a team of microbiologists, optimising assays, and ensuring microbiological integrity across product development and manufacturing processes. Key Responsibilities: Lead and manage a team of microbiologists, providing mentorship and technical direction. Optimise and oversee microbiological assays for sterility, bioburden, endotoxin, environmental monitoring, and antimicrobial susceptibility testing. Develop, validate, and implement new microbiological methods to support product innovation. Ensure regulatory compliance with GMP, ISO 13485, MHRA, and FDA requirements, supporting audits and inspections. Troubleshoot microbiological issues in manufacturing, product development, and quality control. Drive continuous improvement initiatives for microbiological testing, working cross-functionally with R&D, Quality, and Manufacturing teams. Stay updated with industry advancements, regulatory changes, and emerging microbiological technologies, implementing best practices to enhance efficiency and compliance. Essential Skills & Experience: PhD or MSc in Microbiology, Biotechnology, or a related field, with 6+ years of industry experience (biotech, pharma, or industrial microbiology). Strong expertise in microbial identification, molecular techniques (PCR, NGS), biofilm research, sterility assurance, and contamination control. Experience in method development, validation, and troubleshooting of microbiological assays. Demonstrated leadership experience, with a proven track record of mentoring and developing high-performing teams. Strong knowledge of regulatory frameworks (GMP, ISO 13485, FDA, MHRA) and experience supporting audits. Excellent problem-solving skills, with the ability to work both independently and collaboratively. Strong written and verbal communication skills, with experience presenting findings and influencing stakeholders. If you are interested, please apply now or send your CV to
Aug 14, 2025
Full time
Job Title: Senior Microbiology Team Lead Location: Oxford Pay rate: £50 per hour 12 month contract Cpl Life Sciences is working exclusively with a biotech company seeking a Senior Microbiology Team Lead to oversee and drive microbiological research, method development, and regulatory compliance. This leadership role involves managing a team of microbiologists, optimising assays, and ensuring microbiological integrity across product development and manufacturing processes. Key Responsibilities: Lead and manage a team of microbiologists, providing mentorship and technical direction. Optimise and oversee microbiological assays for sterility, bioburden, endotoxin, environmental monitoring, and antimicrobial susceptibility testing. Develop, validate, and implement new microbiological methods to support product innovation. Ensure regulatory compliance with GMP, ISO 13485, MHRA, and FDA requirements, supporting audits and inspections. Troubleshoot microbiological issues in manufacturing, product development, and quality control. Drive continuous improvement initiatives for microbiological testing, working cross-functionally with R&D, Quality, and Manufacturing teams. Stay updated with industry advancements, regulatory changes, and emerging microbiological technologies, implementing best practices to enhance efficiency and compliance. Essential Skills & Experience: PhD or MSc in Microbiology, Biotechnology, or a related field, with 6+ years of industry experience (biotech, pharma, or industrial microbiology). Strong expertise in microbial identification, molecular techniques (PCR, NGS), biofilm research, sterility assurance, and contamination control. Experience in method development, validation, and troubleshooting of microbiological assays. Demonstrated leadership experience, with a proven track record of mentoring and developing high-performing teams. Strong knowledge of regulatory frameworks (GMP, ISO 13485, FDA, MHRA) and experience supporting audits. Excellent problem-solving skills, with the ability to work both independently and collaboratively. Strong written and verbal communication skills, with experience presenting findings and influencing stakeholders. If you are interested, please apply now or send your CV to
Job Title: Senior Microbiology Team Lead Location: London Pay rate: £50 per hour 12 month contract Cpl Life Sciences is working exclusively with a biotech company seeking a Senior Microbiology Team Lead to oversee and drive microbiological research, method development, and regulatory compliance. This leadership role involves managing a team of microbiologists, optimising assays, and ensuring microbiological integrity across product development and manufacturing processes. Key Responsibilities: Lead and manage a team of microbiologists, providing mentorship and technical direction. Optimise and oversee microbiological assays for sterility, bioburden, endotoxin, environmental monitoring, and antimicrobial susceptibility testing. Develop, validate, and implement new microbiological methods to support product innovation. Ensure regulatory compliance with GMP, ISO 13485, MHRA, and FDA requirements, supporting audits and inspections. Troubleshoot microbiological issues in manufacturing, product development, and quality control. Drive continuous improvement initiatives for microbiological testing, working cross-functionally with R&D, Quality, and Manufacturing teams. Stay updated with industry advancements, regulatory changes, and emerging microbiological technologies, implementing best practices to enhance efficiency and compliance. Essential Skills & Experience: PhD or MSc in Microbiology, Biotechnology, or a related field, with 6+ years of industry experience (biotech, pharma, or industrial microbiology). Strong expertise in microbial identification, molecular techniques (PCR, NGS), biofilm research, sterility assurance, and contamination control. Experience in method development, validation, and troubleshooting of microbiological assays. Demonstrated leadership experience, with a proven track record of mentoring and developing high-performing teams. Strong knowledge of regulatory frameworks (GMP, ISO 13485, FDA, MHRA) and experience supporting audits. Excellent problem-solving skills, with the ability to work both independently and collaboratively. Strong written and verbal communication skills, with experience presenting findings and influencing stakeholders. If you are interested, please apply now or send your CV to
Aug 14, 2025
Full time
Job Title: Senior Microbiology Team Lead Location: London Pay rate: £50 per hour 12 month contract Cpl Life Sciences is working exclusively with a biotech company seeking a Senior Microbiology Team Lead to oversee and drive microbiological research, method development, and regulatory compliance. This leadership role involves managing a team of microbiologists, optimising assays, and ensuring microbiological integrity across product development and manufacturing processes. Key Responsibilities: Lead and manage a team of microbiologists, providing mentorship and technical direction. Optimise and oversee microbiological assays for sterility, bioburden, endotoxin, environmental monitoring, and antimicrobial susceptibility testing. Develop, validate, and implement new microbiological methods to support product innovation. Ensure regulatory compliance with GMP, ISO 13485, MHRA, and FDA requirements, supporting audits and inspections. Troubleshoot microbiological issues in manufacturing, product development, and quality control. Drive continuous improvement initiatives for microbiological testing, working cross-functionally with R&D, Quality, and Manufacturing teams. Stay updated with industry advancements, regulatory changes, and emerging microbiological technologies, implementing best practices to enhance efficiency and compliance. Essential Skills & Experience: PhD or MSc in Microbiology, Biotechnology, or a related field, with 6+ years of industry experience (biotech, pharma, or industrial microbiology). Strong expertise in microbial identification, molecular techniques (PCR, NGS), biofilm research, sterility assurance, and contamination control. Experience in method development, validation, and troubleshooting of microbiological assays. Demonstrated leadership experience, with a proven track record of mentoring and developing high-performing teams. Strong knowledge of regulatory frameworks (GMP, ISO 13485, FDA, MHRA) and experience supporting audits. Excellent problem-solving skills, with the ability to work both independently and collaboratively. Strong written and verbal communication skills, with experience presenting findings and influencing stakeholders. If you are interested, please apply now or send your CV to
Our client who is developing an advanced and innovative wound dressing platform ( A dvanced T issue R epair Platform) to substantially, will improve the clinical outcome for patients with Chronic and Complex Wounds whilst maintaining simplicity for care providers. Our Client is on a mission to improve the current standard of care to reduce the physical and psychological impact of poor wound healing on patients that suffer from these wounds. Our clients team is small, so this role will have high risibility within the company so a chance to shine and be rewarded. Our client prides themselves on being a pragmatic, a lean start-up that's driven to deliver world-changing technologies at pace and responding to challenges flexibly and rapidly. Proud of their company values and live them every day: JOB SUMMARY The Quality Assurance and Regulatory Affairs Director will be responsible for developing, implementing, and maintaining quality and regulatory systems in compliance with FDA, ISO, and other global regulatory standards. This role requires deep experience in medical device development - particularly durable medical equipment - combined with working knowledge of regenerative therapies and their evolving regulatory pathways. The ideal candidate will thrive in a fast-paced startup environment and bring strategic leadership, cross-functional collaboration, and executional excellence. ESSENTIAL RESPONSIBILITIES Develop and maintain a robust Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable standards. Lead internal and external audits, CAPA processes, non-conformance investigations, and change control. Oversee design control, risk management (ISO 14971), and product lifecycle quality from R&D to post-market surveillance. Establish and monitor key quality metrics and provide executive-level reporting. Ensure supplier and contract manufacturer compliance through audits, qualification, and continuous monitoring. Define and lead global regulatory strategy for the company's medical device and regenerative medicine products. Prepare and submit CE mark Technical Files, FDA submissions (510(k), IDE, PMA) and other international regulatory dossiers. Serve as the primary regulatory liaison with notified bodies, FDA and other global regulatory authorities. Monitor changes in the regulatory landscape (e.g., FDA, EMA, MDR) and advise leadership on compliance risks and opportunities. Support clinical and preclinical study design from a regulatory perspective THE IDEAL CANDIDATE HAVE A bachelor's degree in engineering, life sciences, or a related field. Minimum of 8-10 years of experience in QA/RA roles within the medical device industry. Proven experience with durable medical equipment (DME) and familiarity with regenerative medicine (e.g., synthetic biodegradable polymers, HCT/Ps, combination products). Direct experience preparing and submitting successful EU MDD and/or MDR and, FDA PMAs. Deep understanding of ISO 13485, FDA QSR, MDSAP, EU MDR, and related standards. A startup mentality: self-starter, hands-on, resourceful, and adaptable. Demonstrated strong leadership and team-building abilities. Excellent communication and cross-functional collaboration skills. A strategic thinker mindset with attention to detail and a proactive problem-solving approach. IN RETURN OUR CLIENT OFFERS A chance to shape the quality and regulatory foundations of a company disrupting the wound care industry. Competitive salary and equity package. Flexible work environment and schedule. Opportunity for significant professional growth and leadership development.
Aug 14, 2025
Full time
Our client who is developing an advanced and innovative wound dressing platform ( A dvanced T issue R epair Platform) to substantially, will improve the clinical outcome for patients with Chronic and Complex Wounds whilst maintaining simplicity for care providers. Our Client is on a mission to improve the current standard of care to reduce the physical and psychological impact of poor wound healing on patients that suffer from these wounds. Our clients team is small, so this role will have high risibility within the company so a chance to shine and be rewarded. Our client prides themselves on being a pragmatic, a lean start-up that's driven to deliver world-changing technologies at pace and responding to challenges flexibly and rapidly. Proud of their company values and live them every day: JOB SUMMARY The Quality Assurance and Regulatory Affairs Director will be responsible for developing, implementing, and maintaining quality and regulatory systems in compliance with FDA, ISO, and other global regulatory standards. This role requires deep experience in medical device development - particularly durable medical equipment - combined with working knowledge of regenerative therapies and their evolving regulatory pathways. The ideal candidate will thrive in a fast-paced startup environment and bring strategic leadership, cross-functional collaboration, and executional excellence. ESSENTIAL RESPONSIBILITIES Develop and maintain a robust Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable standards. Lead internal and external audits, CAPA processes, non-conformance investigations, and change control. Oversee design control, risk management (ISO 14971), and product lifecycle quality from R&D to post-market surveillance. Establish and monitor key quality metrics and provide executive-level reporting. Ensure supplier and contract manufacturer compliance through audits, qualification, and continuous monitoring. Define and lead global regulatory strategy for the company's medical device and regenerative medicine products. Prepare and submit CE mark Technical Files, FDA submissions (510(k), IDE, PMA) and other international regulatory dossiers. Serve as the primary regulatory liaison with notified bodies, FDA and other global regulatory authorities. Monitor changes in the regulatory landscape (e.g., FDA, EMA, MDR) and advise leadership on compliance risks and opportunities. Support clinical and preclinical study design from a regulatory perspective THE IDEAL CANDIDATE HAVE A bachelor's degree in engineering, life sciences, or a related field. Minimum of 8-10 years of experience in QA/RA roles within the medical device industry. Proven experience with durable medical equipment (DME) and familiarity with regenerative medicine (e.g., synthetic biodegradable polymers, HCT/Ps, combination products). Direct experience preparing and submitting successful EU MDD and/or MDR and, FDA PMAs. Deep understanding of ISO 13485, FDA QSR, MDSAP, EU MDR, and related standards. A startup mentality: self-starter, hands-on, resourceful, and adaptable. Demonstrated strong leadership and team-building abilities. Excellent communication and cross-functional collaboration skills. A strategic thinker mindset with attention to detail and a proactive problem-solving approach. IN RETURN OUR CLIENT OFFERS A chance to shape the quality and regulatory foundations of a company disrupting the wound care industry. Competitive salary and equity package. Flexible work environment and schedule. Opportunity for significant professional growth and leadership development.
Job Title: Upstream Bioprocessing Team Leader Location: East London Salary: Competitive, depending on experience Cpl Life Sciences is collaborating with a clinical-stage biotech that specialises in genetic diseases. They are looking to hire an experienced Upstream Bioprocessing Team Leader on a permanent-basis. The ideal candidate will lead and manage the upstream bioprocessing function, ensuring safe, compliant, and reliable manufacturing of clinical and commercial gene therapies. Oversee a team of scientists, ensuring adherence to GMP standards, operational excellence, and continuous improvement within the manufacturing facility. Key Responsibilities: Manage, train, develop, and performance-review a team of up to six Bioprocessing Scientists. Ensure all work is completed in compliance with GMP, Data Integrity, and Good Documentation Practices. Maintain timely and compliant training for all team members before task execution. Oversee and ensure timely closure of GMP documentation, including deviations, CAPAs, change controls, and audit actions. Ensure manufacturing output meets agreed schedules and quality standards. Lead initial quality response during processing and maintain inspection readiness. Manage operational health and safety, ensuring all activities are risk assessed and hazards controlled. Collaborate across departments to meet performance targets and resolve operational issues. Communicate goals, progress, and updates effectively within the team. Promote continuous improvement, coaching team members, and maintaining improvement systems. Set and uphold high standards for cleanroom operations, environmental monitoring, cleaning, and material handling. Key Performance Measures: Zero injuries and incidents in the manufacturing environment. On-time closure of GMP commitments. Adherence to production schedules. Delivery of manufacturing milestones for product development and launch. Positive regulatory inspection results. High employee engagement and retention. Essential Competencies: Strong leadership in cGMP manufacturing of advanced biopharmaceuticals. Proven operational health and safety management in dynamic environments. Effective coaching and development of high-potential teams in growth settings. Excellent organisational, planning, and risk management skills. Analytical mindset with strong problem-solving capability. Experience creating and embedding efficient workflows and performance systems. Skilled in structured problem solving within cross-functional teams. Commitment to fostering continuous improvement culture. Background & Requirements: Degree in Science or Engineering. Solid experience in manufacturing operations, quality systems, and process development lifecycle. Track record in regulatory inspections and audit readiness.
Aug 11, 2025
Full time
Job Title: Upstream Bioprocessing Team Leader Location: East London Salary: Competitive, depending on experience Cpl Life Sciences is collaborating with a clinical-stage biotech that specialises in genetic diseases. They are looking to hire an experienced Upstream Bioprocessing Team Leader on a permanent-basis. The ideal candidate will lead and manage the upstream bioprocessing function, ensuring safe, compliant, and reliable manufacturing of clinical and commercial gene therapies. Oversee a team of scientists, ensuring adherence to GMP standards, operational excellence, and continuous improvement within the manufacturing facility. Key Responsibilities: Manage, train, develop, and performance-review a team of up to six Bioprocessing Scientists. Ensure all work is completed in compliance with GMP, Data Integrity, and Good Documentation Practices. Maintain timely and compliant training for all team members before task execution. Oversee and ensure timely closure of GMP documentation, including deviations, CAPAs, change controls, and audit actions. Ensure manufacturing output meets agreed schedules and quality standards. Lead initial quality response during processing and maintain inspection readiness. Manage operational health and safety, ensuring all activities are risk assessed and hazards controlled. Collaborate across departments to meet performance targets and resolve operational issues. Communicate goals, progress, and updates effectively within the team. Promote continuous improvement, coaching team members, and maintaining improvement systems. Set and uphold high standards for cleanroom operations, environmental monitoring, cleaning, and material handling. Key Performance Measures: Zero injuries and incidents in the manufacturing environment. On-time closure of GMP commitments. Adherence to production schedules. Delivery of manufacturing milestones for product development and launch. Positive regulatory inspection results. High employee engagement and retention. Essential Competencies: Strong leadership in cGMP manufacturing of advanced biopharmaceuticals. Proven operational health and safety management in dynamic environments. Effective coaching and development of high-potential teams in growth settings. Excellent organisational, planning, and risk management skills. Analytical mindset with strong problem-solving capability. Experience creating and embedding efficient workflows and performance systems. Skilled in structured problem solving within cross-functional teams. Commitment to fostering continuous improvement culture. Background & Requirements: Degree in Science or Engineering. Solid experience in manufacturing operations, quality systems, and process development lifecycle. Track record in regulatory inspections and audit readiness.
Position Information JobTitle Recruitment Partner Division PSRecruitment - Bookings Team StartDate Immediate Location(s) Onsite- Stockport ReportingTo DeputyManager The PS Recruitment Bookings Team are seeking to hire a Recruitment Partner to support in the running of all aspects of Recruitment in a busy social care recruitment team. PS Recruitment is an expanding recruitment company specialising in social care, providing temporary and permanent staffing solutions tailored to the bespoke needs of our clients. This role is a full-time office-based position, located in the centre of Stockport. Duties of the role include but are not limited to the following: Actively engage in business development activities to secure new clients, generate new business opportunities, and approach prospective clients to drive company growth. Matching candidates to temporary assignments Interviewing a wide variety of candidates and providing a consultative service to find them the right job. Resourcing candidates who meet the company's recruitment criteria Completing compliance checks as per the candidate and contractual requirements Contacting clients to check on requirements and in order to maintain relationships Conducting business development calls over the phone Conducting both sales and service review meetings at the clients' premises. Identifying and creating relationships with new clients Manage client correspondence and calls in a timely and professional manner. Using social media platforms like LinkedIn to promote your profile and expertise in the Social Care Recruitment Sector whilst promoting the business. Participation in the company's out of hours service as part of a team on a rota basis Role Requirements Experience of working in a fast paced, busy business environment, or experience gained in a HR/administration, agency or in-house recruitment role, would be ideal but not essential for this role. Fantastic communication skills including the ability to compose professional emails and be confident when using the telephone Able to work as part of a team, but can also use initiative and work independently when required Proficient or Experienced in the use of MS Office (Word, Excel, Outlook, PowerPoint). About Us Servisource, part of the Cpl Group, is a leading provider of high quality and innovative recruitment, care, and support services, with over 20 years' experience across a number of sector specialities With over 200 employees in 10 offices across Ireland and the United Kingdom in Dublin, Dundalk, Cork, Galway, Limerick, Belfast, Leeds, Redcar, Middlesbrough and Bradford, we provide a local and personal service with a national and international reach. With ambitious strategic growth plans to further grow within the UK and expand into the US market, it is a very exciting time to join our company. Organisational Benefits We are committed to providing a positive employee experience where everyone can gain access to meaningful and challenging work with opportunities for growth and career progression. As part of the Cpl Group, we recently listed as the 7th Best Place To Work in the large category in Ireland, we are recognised as one of the Best Places To Work for Women, and we are also listed as 24 th in the Best Workplaces Europe 2023 (Best Large Workplaces Category) of 3,000 eligible organisations across 4 categories. Cpl also have attained a Gold Award by Investors in Diversity for our commitment to Diversity, Equity and Inclusion. . What we offer: Competitive Financial and Benefits package Flexibility and Smart Working Practices Health & Wellbeing initiatives Career Development Progression opportunities Further Learning & Development opportunities Vibrant Sports & Social club Our Core Values are an integral part of our organisational culture.The ideal candidate willpossess the ability to understand, demonstrate and apply our Core Values: C ustomer focused A ccountability R esponsibility E mpowerment E ffective communication R espect Due to the nature of the business, management reserves the right to amend the job description in line with the needs of the business and current economic climate All applications will be treated with the strictest of confidence If you wish to apply for the above-named role, please send an updated CV to quoting the job reference number JO-83 in the subject bar of your email.
Aug 06, 2025
Full time
Position Information JobTitle Recruitment Partner Division PSRecruitment - Bookings Team StartDate Immediate Location(s) Onsite- Stockport ReportingTo DeputyManager The PS Recruitment Bookings Team are seeking to hire a Recruitment Partner to support in the running of all aspects of Recruitment in a busy social care recruitment team. PS Recruitment is an expanding recruitment company specialising in social care, providing temporary and permanent staffing solutions tailored to the bespoke needs of our clients. This role is a full-time office-based position, located in the centre of Stockport. Duties of the role include but are not limited to the following: Actively engage in business development activities to secure new clients, generate new business opportunities, and approach prospective clients to drive company growth. Matching candidates to temporary assignments Interviewing a wide variety of candidates and providing a consultative service to find them the right job. Resourcing candidates who meet the company's recruitment criteria Completing compliance checks as per the candidate and contractual requirements Contacting clients to check on requirements and in order to maintain relationships Conducting business development calls over the phone Conducting both sales and service review meetings at the clients' premises. Identifying and creating relationships with new clients Manage client correspondence and calls in a timely and professional manner. Using social media platforms like LinkedIn to promote your profile and expertise in the Social Care Recruitment Sector whilst promoting the business. Participation in the company's out of hours service as part of a team on a rota basis Role Requirements Experience of working in a fast paced, busy business environment, or experience gained in a HR/administration, agency or in-house recruitment role, would be ideal but not essential for this role. Fantastic communication skills including the ability to compose professional emails and be confident when using the telephone Able to work as part of a team, but can also use initiative and work independently when required Proficient or Experienced in the use of MS Office (Word, Excel, Outlook, PowerPoint). About Us Servisource, part of the Cpl Group, is a leading provider of high quality and innovative recruitment, care, and support services, with over 20 years' experience across a number of sector specialities With over 200 employees in 10 offices across Ireland and the United Kingdom in Dublin, Dundalk, Cork, Galway, Limerick, Belfast, Leeds, Redcar, Middlesbrough and Bradford, we provide a local and personal service with a national and international reach. With ambitious strategic growth plans to further grow within the UK and expand into the US market, it is a very exciting time to join our company. Organisational Benefits We are committed to providing a positive employee experience where everyone can gain access to meaningful and challenging work with opportunities for growth and career progression. As part of the Cpl Group, we recently listed as the 7th Best Place To Work in the large category in Ireland, we are recognised as one of the Best Places To Work for Women, and we are also listed as 24 th in the Best Workplaces Europe 2023 (Best Large Workplaces Category) of 3,000 eligible organisations across 4 categories. Cpl also have attained a Gold Award by Investors in Diversity for our commitment to Diversity, Equity and Inclusion. . What we offer: Competitive Financial and Benefits package Flexibility and Smart Working Practices Health & Wellbeing initiatives Career Development Progression opportunities Further Learning & Development opportunities Vibrant Sports & Social club Our Core Values are an integral part of our organisational culture.The ideal candidate willpossess the ability to understand, demonstrate and apply our Core Values: C ustomer focused A ccountability R esponsibility E mpowerment E ffective communication R espect Due to the nature of the business, management reserves the right to amend the job description in line with the needs of the business and current economic climate All applications will be treated with the strictest of confidence If you wish to apply for the above-named role, please send an updated CV to quoting the job reference number JO-83 in the subject bar of your email.
Job Role: Regulatory Medical Writing Lead Job Type: Full-time, permanent. Job Location: UK, Remote - Travel 1x a quarter to the office in Surrey. Remuneration: £80,000 - £99,000 plus car allowance and bonus. An opportunity to join a growing specialty pharmaceutical company that focuses on developing innovative treatments for hard-to-treat diseases, with key areas including immuno-oncology, gene therapy, mitochondrial biology, blindness and regeneration, and targeted protein degradation. Acts as a Global Medical Writing Lead, generally in mid- to late-stage development global project teams. The individual provides leadership with respect to all program documents and may act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs. The individual independently analyzes proposed program, study, and related documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency. The individual reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history; ensures a consistent pattern of successful completion of assigned responsibilities within a program resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements; and provides intellectual leadership and contributes document knowledge and expertise to the global project team. Responsibilities: Acts as a primary lead for all assigned programs (generally mid- to late-stage development). As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team. May act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs. Reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history, ensuring a consistent pattern of successful completion of assigned responsibilities resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements. For all documents within a program, independently implements adjustments in specific document content within framework of provided templates in order to fit the needs of specific document/core team requirements. Participates in standards and processes initiatives/activities and other departmental project activities (up to a total of 15% of time). May participate in a multidiscipline productivity or process initiative. Supports Line Management in the improvement of departmental performance and outsourcing alliances through analysis and evaluation of metrics and performance data. Required Qualifications: BA/BS degree or equivalent, 10+ years relevant experience. Preferred: PhD/Pharm D or MS/MA/MPH with at least 10 years as a writing professional in pharmaceutical industry, with 2-5 years' experience in managing/supervising activities associated with the creation of regulated documents in the pharmaceutical industry. Technical expert on all document types produced by medical writing. Demonstrated and substantial experience in leading/managing the creation of IND/IMPD and NDA/MAA components, briefing documents, responses to regulatory authorities. Preferred experience in preparing for advisory committees. Strong communication and leadership skills; strategic thinker. Please note this role is a senior role within the business so you MUST have extensive experience in RA medical writing and have excellent communication skills. The role DOES NOT offer job sponsorship so you must hold the full right to work in the UK and be based in the United Kingdom. For more information please reach out to me at
Jul 28, 2025
Full time
Job Role: Regulatory Medical Writing Lead Job Type: Full-time, permanent. Job Location: UK, Remote - Travel 1x a quarter to the office in Surrey. Remuneration: £80,000 - £99,000 plus car allowance and bonus. An opportunity to join a growing specialty pharmaceutical company that focuses on developing innovative treatments for hard-to-treat diseases, with key areas including immuno-oncology, gene therapy, mitochondrial biology, blindness and regeneration, and targeted protein degradation. Acts as a Global Medical Writing Lead, generally in mid- to late-stage development global project teams. The individual provides leadership with respect to all program documents and may act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs. The individual independently analyzes proposed program, study, and related documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency. The individual reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history; ensures a consistent pattern of successful completion of assigned responsibilities within a program resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements; and provides intellectual leadership and contributes document knowledge and expertise to the global project team. Responsibilities: Acts as a primary lead for all assigned programs (generally mid- to late-stage development). As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team. May act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs. Reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history, ensuring a consistent pattern of successful completion of assigned responsibilities resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements. For all documents within a program, independently implements adjustments in specific document content within framework of provided templates in order to fit the needs of specific document/core team requirements. Participates in standards and processes initiatives/activities and other departmental project activities (up to a total of 15% of time). May participate in a multidiscipline productivity or process initiative. Supports Line Management in the improvement of departmental performance and outsourcing alliances through analysis and evaluation of metrics and performance data. Required Qualifications: BA/BS degree or equivalent, 10+ years relevant experience. Preferred: PhD/Pharm D or MS/MA/MPH with at least 10 years as a writing professional in pharmaceutical industry, with 2-5 years' experience in managing/supervising activities associated with the creation of regulated documents in the pharmaceutical industry. Technical expert on all document types produced by medical writing. Demonstrated and substantial experience in leading/managing the creation of IND/IMPD and NDA/MAA components, briefing documents, responses to regulatory authorities. Preferred experience in preparing for advisory committees. Strong communication and leadership skills; strategic thinker. Please note this role is a senior role within the business so you MUST have extensive experience in RA medical writing and have excellent communication skills. The role DOES NOT offer job sponsorship so you must hold the full right to work in the UK and be based in the United Kingdom. For more information please reach out to me at
Job Title: Regulatory Affairs Manager - Line Management (Essential) Job Type: Full time, Permanent Location: High Wycombe, Buckinghamshire, UK (Hybrid) Remuneration: Up to £80,000 + 7.5% Bonus An opportunity working for a growing speciality pharmaceutical business as a Regulatory Manager. The role reports to Director of Regulatory Affairs. We're looking for an experienced Regulatory Affairs Manager to lead regulatory strategy and ensure compliance across global markets. This role is ideal for someone with a strong understanding of regulatory frameworks, excellent attention to detail, and the ability to work cross-functionally to support product development and approvals. This role is responsible for regulatory efforts for EU and UK products, particularly post-Brexit, including MAH. The primary objective is to effectively fulfil MAH responsibilities for the UK and EU business. Within this role, you will manage a team of 4 officers. Previous line management is a must as well as real technical expertise: Day-day responsibilities Portfolio Management : Specialise in managing regulatory affairs for EU products within the portfolio, ensuring adherence to relevant regulations and standards. Gap Analysis : Conduct thorough assessments of Marketing Authorisation (MA) versus manufacturing documents to identify and address any discrepancies. New MA Applications : Lead the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures. Geographical Expansion : Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards. RA Support for New Product Development : Provide regulatory guidance and support to the New Product Development team to ensure compliance with EU regulations from the outset. In-licensing Support : Offer regulatory support for in-licensing activities, ensuring smooth integration of acquired products into our portfolio. MA Compliance Maintenance : Ensure ongoing compliance and maintenance of Marketing Authorisations for the assigned portfolio of In-house manufacturing and Contract Manufacturing Organisations and oversee compliance for the team. Safety Variations: Ensure safety variations e.g. updating in line with reference products, PRAC recommendations, and Internal Safety updates for the assigned portfolio and oversee the Team submitting their assigned safety variations. Change Control Management : Manage regulatory change controls, Corrective and Preventive Actions (CAPAs), and deviations, with familiarity with the SAP system preferred. Implementation of Patient Information Leaflets (PILs) and Mock-ups: Oversee the comprehensive execution of PILs and mock-ups implementation, including finalising all procedural aspects, managing relevant national phases in each member state, collaborating with the artwork team and local affiliates/partners to create PIL mock-ups and artwork, and coordinating all necessary processes to ensure the timely implementation of new PIL mock-ups and artwork. Skills/Experience Experience in the pharmaceutical industry minimum 8 years. A science degree. Leadership and developing team's minimum 4 years. Working in a global matrix organisation and collaborating at all levels including external authorities and partners. Mutual Recognition and Decentralised Procedures. Philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic "necessary" function. Commercial sense, combined with an absolute commitment to high regulatory standards. Planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail. Benefits: Competitive salary(up to 80k) 25 days annual leave, rising to 30 with length of service plus bank holidays (prorated) Holiday Buy/Sell - an opportunity to buy or sell up to an additional 5 days of holiday 7.5% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility) Bravo Benefits Platform - offering a variety of discounts, financial support, My MindPal, wellbeing app, menopause support and more Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility) Private Healthcare with an additional Medicash health cash plan Working hours information Monday - Friday 37.5hrs per week, hybrid role. This role does not offer sponsorship, you MUST be based in the UK and hold the FULL right to work. You MUST be able to get to site 3x per week. For more information, please reach out to
Jul 25, 2025
Full time
Job Title: Regulatory Affairs Manager - Line Management (Essential) Job Type: Full time, Permanent Location: High Wycombe, Buckinghamshire, UK (Hybrid) Remuneration: Up to £80,000 + 7.5% Bonus An opportunity working for a growing speciality pharmaceutical business as a Regulatory Manager. The role reports to Director of Regulatory Affairs. We're looking for an experienced Regulatory Affairs Manager to lead regulatory strategy and ensure compliance across global markets. This role is ideal for someone with a strong understanding of regulatory frameworks, excellent attention to detail, and the ability to work cross-functionally to support product development and approvals. This role is responsible for regulatory efforts for EU and UK products, particularly post-Brexit, including MAH. The primary objective is to effectively fulfil MAH responsibilities for the UK and EU business. Within this role, you will manage a team of 4 officers. Previous line management is a must as well as real technical expertise: Day-day responsibilities Portfolio Management : Specialise in managing regulatory affairs for EU products within the portfolio, ensuring adherence to relevant regulations and standards. Gap Analysis : Conduct thorough assessments of Marketing Authorisation (MA) versus manufacturing documents to identify and address any discrepancies. New MA Applications : Lead the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures. Geographical Expansion : Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards. RA Support for New Product Development : Provide regulatory guidance and support to the New Product Development team to ensure compliance with EU regulations from the outset. In-licensing Support : Offer regulatory support for in-licensing activities, ensuring smooth integration of acquired products into our portfolio. MA Compliance Maintenance : Ensure ongoing compliance and maintenance of Marketing Authorisations for the assigned portfolio of In-house manufacturing and Contract Manufacturing Organisations and oversee compliance for the team. Safety Variations: Ensure safety variations e.g. updating in line with reference products, PRAC recommendations, and Internal Safety updates for the assigned portfolio and oversee the Team submitting their assigned safety variations. Change Control Management : Manage regulatory change controls, Corrective and Preventive Actions (CAPAs), and deviations, with familiarity with the SAP system preferred. Implementation of Patient Information Leaflets (PILs) and Mock-ups: Oversee the comprehensive execution of PILs and mock-ups implementation, including finalising all procedural aspects, managing relevant national phases in each member state, collaborating with the artwork team and local affiliates/partners to create PIL mock-ups and artwork, and coordinating all necessary processes to ensure the timely implementation of new PIL mock-ups and artwork. Skills/Experience Experience in the pharmaceutical industry minimum 8 years. A science degree. Leadership and developing team's minimum 4 years. Working in a global matrix organisation and collaborating at all levels including external authorities and partners. Mutual Recognition and Decentralised Procedures. Philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic "necessary" function. Commercial sense, combined with an absolute commitment to high regulatory standards. Planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail. Benefits: Competitive salary(up to 80k) 25 days annual leave, rising to 30 with length of service plus bank holidays (prorated) Holiday Buy/Sell - an opportunity to buy or sell up to an additional 5 days of holiday 7.5% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility) Bravo Benefits Platform - offering a variety of discounts, financial support, My MindPal, wellbeing app, menopause support and more Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility) Private Healthcare with an additional Medicash health cash plan Working hours information Monday - Friday 37.5hrs per week, hybrid role. This role does not offer sponsorship, you MUST be based in the UK and hold the FULL right to work. You MUST be able to get to site 3x per week. For more information, please reach out to
Join One of the Fastest-Growing Tech Companies as a German-Speaking Account Executive! We're partnering with a dynamic and rapidly expanding tech company seeking a passionate and driven German-speaking sales professional to join their growing team of Account Executives. About the Role As an Account Executive, you'll take full ownership of the sales process-from prospecting to closing deals. You'll build meaningful partnerships with top-tier companies and organizations across your designated region. Key Responsibilities Manage the end-to-end sales cycle Drive business growth by expanding the client base Strategically manage multiple prospects and maintain a strong pipeline to meet or exceed targets Present and demonstrate the value of the company's products to potential clients What You Bring Fluent in both German and English 1+ years of experience in a fast-paced sales environment Proven ability to qualify leads, position offerings, and close deals Target-driven with a positive, energetic approach A collaborative mindset and willingness to go the extra mile What's in It for You Competitive and flexible compensation package Generous commission structure Healthcare and pension plan Permanent full-time contract Work remotely from anywhere in the UK, choose a hybrid model, or join the London office Clear opportunities for career growth Employee stock options -
Jul 15, 2025
Full time
Join One of the Fastest-Growing Tech Companies as a German-Speaking Account Executive! We're partnering with a dynamic and rapidly expanding tech company seeking a passionate and driven German-speaking sales professional to join their growing team of Account Executives. About the Role As an Account Executive, you'll take full ownership of the sales process-from prospecting to closing deals. You'll build meaningful partnerships with top-tier companies and organizations across your designated region. Key Responsibilities Manage the end-to-end sales cycle Drive business growth by expanding the client base Strategically manage multiple prospects and maintain a strong pipeline to meet or exceed targets Present and demonstrate the value of the company's products to potential clients What You Bring Fluent in both German and English 1+ years of experience in a fast-paced sales environment Proven ability to qualify leads, position offerings, and close deals Target-driven with a positive, energetic approach A collaborative mindset and willingness to go the extra mile What's in It for You Competitive and flexible compensation package Generous commission structure Healthcare and pension plan Permanent full-time contract Work remotely from anywhere in the UK, choose a hybrid model, or join the London office Clear opportunities for career growth Employee stock options -
London 6 month contract opportunity Can be fully remote-based in the UK Immediate start We are delighted to be partnered with an industry-leading pharmaceutical company who are currently looking for an experienced Medical Writer to join them on a 6-month contract basis. This position will be focused on Publications and will be responsible for: - Managing all medical communication deliverables - including abstracts, manuscripts, slide decks, publication plans, meeting materials and posters. - Creating high quality, scientifically accurate content that adheres to project briefs and timelines. - Performing quality checks and proofreading all material/content. - Ensuring that all industry guidelines and regulations are met as required. We welcome applications from candidates who are able to demonstrate the following: - At least 5 years of medical communications experience - within a medical writing role, either agency-side or in-house. - Publications experience - with an understanding of relevant publication processes and guidelines. - A University degree, or equivalent qualification, within a Scientific discipline - MSc, PhD or MD is advantageous. Please apply via this advertisement including an updated version of your CV and we look forward to hearing from you soon.
Jul 15, 2025
Full time
London 6 month contract opportunity Can be fully remote-based in the UK Immediate start We are delighted to be partnered with an industry-leading pharmaceutical company who are currently looking for an experienced Medical Writer to join them on a 6-month contract basis. This position will be focused on Publications and will be responsible for: - Managing all medical communication deliverables - including abstracts, manuscripts, slide decks, publication plans, meeting materials and posters. - Creating high quality, scientifically accurate content that adheres to project briefs and timelines. - Performing quality checks and proofreading all material/content. - Ensuring that all industry guidelines and regulations are met as required. We welcome applications from candidates who are able to demonstrate the following: - At least 5 years of medical communications experience - within a medical writing role, either agency-side or in-house. - Publications experience - with an understanding of relevant publication processes and guidelines. - A University degree, or equivalent qualification, within a Scientific discipline - MSc, PhD or MD is advantageous. Please apply via this advertisement including an updated version of your CV and we look forward to hearing from you soon.
The company is building a culture where amazing people (like you) can do their best work. If you're ready to grow your career and help millions of organizations grow better, you've come to the right place. As a Mid-Market Account Executive DACH, you will be engaging directly with small to medium-sized businesses, helping them to grow. You will use proactive and inbound selling strategies to find and close new business and increase the customer's usage of the company's platform over time. Role Overview Manage the full sales cycle from prospect to close. Develop and be responsible for your own annual, quarterly, and monthly territory business plan. Find new prospects from both inbound and self-sourced leads. Run qualification calls with C-level executives and department leaders. Close both new business and install base at or above quota on a monthly cadence. Your Profile/Skillset Proficiency in English and German. 2+ years of experience in a fast-paced sales environment and quota carrying role. Ability to qualify, position, and close. Enthusiastic about meeting targets. Excellent team player, always ready to go an extra mile. Must have UK settlement status or UK passport. What's on offer Competitive & negotiable package. Healthcare and Pension Scheme. Generous commission structure. Full-time permanent contract. Can be fully remote (In England), hybrid, or London office based. Exciting career progression opportunities. Employee stock benefits. If you are interested, please send me a direct email to or apply through this link.
Feb 21, 2025
Full time
The company is building a culture where amazing people (like you) can do their best work. If you're ready to grow your career and help millions of organizations grow better, you've come to the right place. As a Mid-Market Account Executive DACH, you will be engaging directly with small to medium-sized businesses, helping them to grow. You will use proactive and inbound selling strategies to find and close new business and increase the customer's usage of the company's platform over time. Role Overview Manage the full sales cycle from prospect to close. Develop and be responsible for your own annual, quarterly, and monthly territory business plan. Find new prospects from both inbound and self-sourced leads. Run qualification calls with C-level executives and department leaders. Close both new business and install base at or above quota on a monthly cadence. Your Profile/Skillset Proficiency in English and German. 2+ years of experience in a fast-paced sales environment and quota carrying role. Ability to qualify, position, and close. Enthusiastic about meeting targets. Excellent team player, always ready to go an extra mile. Must have UK settlement status or UK passport. What's on offer Competitive & negotiable package. Healthcare and Pension Scheme. Generous commission structure. Full-time permanent contract. Can be fully remote (In England), hybrid, or London office based. Exciting career progression opportunities. Employee stock benefits. If you are interested, please send me a direct email to or apply through this link.
I am looking for a Quality Assurance Manager to join a medical equipment manufacturing company based near Bristol. The ideal candidate will have either IVD or medical device industry experience and a solid understanding of the operation and maintenance of a ISO13485 structured quality management system. The Position: To act as a conduit for the effective operation of the QMS. To provide a professional quality assurance support role for the internal organisation, supplier quality interfaces, and customer quality interfaces as required. A Quality professional with a sound practical background in the application of ISO13485 quality principles within the IVD or Medical Devices Industry. The successful applicant will be able to demonstrate the ability to support the implementation and maintenance of an integrated QMS that meets the requirements of ISO13485 / 21 CFR Part 820 compliance, other regulations, and effective business processes. A self-motivated individual is required as this role will involve working with and across all internal departments. The role may also require communication with suppliers and customers. The ideal applicant will have experience with software validation, either as a stand-alone medical device or incorporated within a medical device. Responsibilities: Advise and support organizational leaders in furthering the company's goals. Prioritize, assign, and monitor the workload of QA team members. Lead and support the implementation of QMS processes. Act as a system administrator for the eQMS system (QT9). Train employees companywide in QMS procedures owned by QA, as required. Audit processes and QMS procedures for compliance and effectiveness. Support and advise operational staff in the execution of the QMS processes. Monitor key performance indicators. Support the ongoing development of the Quality Management System and the application of other relevant regulatory requirements. Provide backup QA team resource for the day-to-day administrative requirements of the quality management system. Identify quality improvements and implement efficiencies. Education, Experience and Demonstrated Skills: BSc in a relevant Scientific discipline, or equivalent experience. Recognised qualification from a relevant quality institute. A minimum of 5 years hands-on supporting the development, operation and maintenance of a ISO13485 structured quality management system. A minimum of 2 years' hands-on experience in the IVD or medical device industry. Skilled in collaboration and working in cross-functional groups to achieve positive outcomes. Experience in process-based auditing. Strong understanding of ISO13485. Strong understanding of 21 CFR Part 820. Basic understanding of IVD Directive (98/79/EC). Basic understanding of ISO14971. Ability to write controlled documents like SOPs. Ability to train others. An understanding of the role of quality in a business context. Strong verbal & written communication. Ability to operate electronic QMS systems (including document control). Working to deadlines. Attention to detail. Ability to formulate and ask open-ended questions. Competent in word processing, spreadsheets, databases. For interested applicants, please submit resumes to .
Feb 18, 2025
Full time
I am looking for a Quality Assurance Manager to join a medical equipment manufacturing company based near Bristol. The ideal candidate will have either IVD or medical device industry experience and a solid understanding of the operation and maintenance of a ISO13485 structured quality management system. The Position: To act as a conduit for the effective operation of the QMS. To provide a professional quality assurance support role for the internal organisation, supplier quality interfaces, and customer quality interfaces as required. A Quality professional with a sound practical background in the application of ISO13485 quality principles within the IVD or Medical Devices Industry. The successful applicant will be able to demonstrate the ability to support the implementation and maintenance of an integrated QMS that meets the requirements of ISO13485 / 21 CFR Part 820 compliance, other regulations, and effective business processes. A self-motivated individual is required as this role will involve working with and across all internal departments. The role may also require communication with suppliers and customers. The ideal applicant will have experience with software validation, either as a stand-alone medical device or incorporated within a medical device. Responsibilities: Advise and support organizational leaders in furthering the company's goals. Prioritize, assign, and monitor the workload of QA team members. Lead and support the implementation of QMS processes. Act as a system administrator for the eQMS system (QT9). Train employees companywide in QMS procedures owned by QA, as required. Audit processes and QMS procedures for compliance and effectiveness. Support and advise operational staff in the execution of the QMS processes. Monitor key performance indicators. Support the ongoing development of the Quality Management System and the application of other relevant regulatory requirements. Provide backup QA team resource for the day-to-day administrative requirements of the quality management system. Identify quality improvements and implement efficiencies. Education, Experience and Demonstrated Skills: BSc in a relevant Scientific discipline, or equivalent experience. Recognised qualification from a relevant quality institute. A minimum of 5 years hands-on supporting the development, operation and maintenance of a ISO13485 structured quality management system. A minimum of 2 years' hands-on experience in the IVD or medical device industry. Skilled in collaboration and working in cross-functional groups to achieve positive outcomes. Experience in process-based auditing. Strong understanding of ISO13485. Strong understanding of 21 CFR Part 820. Basic understanding of IVD Directive (98/79/EC). Basic understanding of ISO14971. Ability to write controlled documents like SOPs. Ability to train others. An understanding of the role of quality in a business context. Strong verbal & written communication. Ability to operate electronic QMS systems (including document control). Working to deadlines. Attention to detail. Ability to formulate and ask open-ended questions. Competent in word processing, spreadsheets, databases. For interested applicants, please submit resumes to .