Functional Functional Always active The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network. Preferences Preferences The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user. Statistics Statistics The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you. Marketing Marketing The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes. Salary of up to £40k (depending on experience) Sonrai is a Belfast-based AI data discovery company on a mission to help save patient lives through AI technology. We enable Biotech and Pharma companies to reduce the cost, time, and risk from early discovery to clinical trials, accelerate drug, biomarker, and diagnostics, maintain a secure and compliant Trusted Research Environment, and effectively and safely manage data. Our bioinformatic cloud product is sold on a licence fee basis, along with accompanying data science and software engineering professional services. Our clients and partners already include some of the biggest names around, and we're now looking to appoint a Customer Success Manager to help deliver our strategy. It's a great time to be joining Sonrai; over the past two years, we have: Successfully grown our customer base across a range of biotech and pharma organisations globally Grown our team to 35+ and won multiple awards Opportunity & Responsibilities The Customer Success Manager will work closely with the Director of Customer Success and the wider Sonrai team to enable success of clients and partners, and promote client growth and retention. Specific Responsibilities include: Ensure clients within your portfolio have the right tools and support to succeed. Establish strong professional relationships with each client and develop a solid understanding of their current needs and anticipate future needs. Be the primary point of contact for your clients and manage all aspects of service delivery within your portfolio. Develop and maintain sufficient knowledge of Sonrai products to carry out the role effectively. Work closely with technical teams to ensure client needs are met. Plan and lead internal and external meetings. Identify appropriate opportunities for account growth. Support client retention by planning ahead for client contract renewal. Report regularly to the Director of Customer Success on client account progress and issues. Generate Key Performance Metrics in line with business objectives. Maintain compliance with Sonrai's quality management system. UK and international travel may be required as necessary to meet with clients. Frequency of travel is dictated by business need, estimated at 1-3 short visits per year. You will have: A Life sciences, bioinformatics or software-related bachelors degree (2.1 or higher) or equivalent (relevant post graduate qualification desirable) 2+ years relevant professional experience in a customer facing role (such as at a CRO, or PAAS or SAAS company) A good understanding of the role of biomarkers and data analytics in precision medicine. Excellent project management skills including ability to plan and prioritise tasks whilst maintaining a high level of accuracy in all work carried out. Experience successfully managing projects in a professional environment. Demonstrate confident, effective and professional communication skills (written, oral and presentational). Evidence of ability to manage time and workload effectively while in a remote working environment. Ability to deal skillfully and promptly with new situations in order to identify feasible and practical solutions. Ability to work across a range of functional and organisational boundaries. Demonstrated ability to work successfully both independently and within a collaborative team including fostering trusting working relationships with internal teams and clients. Proficiency in use of project management tools. Right to work in the UK or Ireland for a minimum of 2 years from the date of any job offer from Sonrai Proficient to a relevant level of Business English Competitive salary and commission structure Employer pension contribution Enhanced Maternity Leave and Paternity Leave Opportunity to work from home 25 days annual leave plus 10 public/bank holidays Training budget / strong focus on staff development
Nov 07, 2025
Full time
Functional Functional Always active The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network. Preferences Preferences The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user. Statistics Statistics The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you. Marketing Marketing The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes. Salary of up to £40k (depending on experience) Sonrai is a Belfast-based AI data discovery company on a mission to help save patient lives through AI technology. We enable Biotech and Pharma companies to reduce the cost, time, and risk from early discovery to clinical trials, accelerate drug, biomarker, and diagnostics, maintain a secure and compliant Trusted Research Environment, and effectively and safely manage data. Our bioinformatic cloud product is sold on a licence fee basis, along with accompanying data science and software engineering professional services. Our clients and partners already include some of the biggest names around, and we're now looking to appoint a Customer Success Manager to help deliver our strategy. It's a great time to be joining Sonrai; over the past two years, we have: Successfully grown our customer base across a range of biotech and pharma organisations globally Grown our team to 35+ and won multiple awards Opportunity & Responsibilities The Customer Success Manager will work closely with the Director of Customer Success and the wider Sonrai team to enable success of clients and partners, and promote client growth and retention. Specific Responsibilities include: Ensure clients within your portfolio have the right tools and support to succeed. Establish strong professional relationships with each client and develop a solid understanding of their current needs and anticipate future needs. Be the primary point of contact for your clients and manage all aspects of service delivery within your portfolio. Develop and maintain sufficient knowledge of Sonrai products to carry out the role effectively. Work closely with technical teams to ensure client needs are met. Plan and lead internal and external meetings. Identify appropriate opportunities for account growth. Support client retention by planning ahead for client contract renewal. Report regularly to the Director of Customer Success on client account progress and issues. Generate Key Performance Metrics in line with business objectives. Maintain compliance with Sonrai's quality management system. UK and international travel may be required as necessary to meet with clients. Frequency of travel is dictated by business need, estimated at 1-3 short visits per year. You will have: A Life sciences, bioinformatics or software-related bachelors degree (2.1 or higher) or equivalent (relevant post graduate qualification desirable) 2+ years relevant professional experience in a customer facing role (such as at a CRO, or PAAS or SAAS company) A good understanding of the role of biomarkers and data analytics in precision medicine. Excellent project management skills including ability to plan and prioritise tasks whilst maintaining a high level of accuracy in all work carried out. Experience successfully managing projects in a professional environment. Demonstrate confident, effective and professional communication skills (written, oral and presentational). Evidence of ability to manage time and workload effectively while in a remote working environment. Ability to deal skillfully and promptly with new situations in order to identify feasible and practical solutions. Ability to work across a range of functional and organisational boundaries. Demonstrated ability to work successfully both independently and within a collaborative team including fostering trusting working relationships with internal teams and clients. Proficiency in use of project management tools. Right to work in the UK or Ireland for a minimum of 2 years from the date of any job offer from Sonrai Proficient to a relevant level of Business English Competitive salary and commission structure Employer pension contribution Enhanced Maternity Leave and Paternity Leave Opportunity to work from home 25 days annual leave plus 10 public/bank holidays Training budget / strong focus on staff development
At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. We've been recognised as a Great Place to Work ! And we're proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women. At Eakin Healthcare, we're united by one mission: working together to improve lives - just like we've been doing for over five decades. WHY JOIN US? We're good at what we do - come and join us and you can benefit from: Blended Working Bonus 25 days holiday plus bank holidays (rising to 28) Option to buy holiday days Health Cash Plan Pension Life Assurance Enhanced Maternity/Paternity Cycle to Work Scheme Referral Scheme Long Service Awards Free Parking ABOUT THE ROLE A member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a key role in the Operations Compliance Team, provide business support and guidance in line with Compliance and Eakin Healthcare Strategies. This role in based in Coleraine, Northern Ireland and is an excellent opportunity for an individual to work closely with both site-based functions and colleagues and wider group colleagues in the Group Operations Compliance Team. KEY RESPONSIBILITIES Involved in the creation, improvement and maintenance of regulatory compliant Quality Management System (QMS) documentation (and training thereof) that will include, but not be limited to: QMS reports and analysis of reports for review by the Quality Manager. Quality reports for review at Management Review meetings. Reviewing and actioning feedback from customers. Support creation, revision and maintenance of Operating Procedures, Quality Forms and Work Instructions. Support QMS studies and reports e.g. stability studies. Identification, investigation and documentation of product and process non-conformances document root cause and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements. Support and execute the timely release of finished medical devices to ensure schedules are maintained and stock available. Support and co-ordinate the accurate completion, retention, and review of product release documentation, liaising where necessary with the relevant internal stakeholders and ensuring all product release documentation complies with the appropriate site regulatory certification and standards (ISO13485, MDSAP, GMP, GDP, FDA CFR). Inform and collate quality feedback data ensuring that key information is relayed to the Quality Manager. Support and perform internal audits under guidance from the QHSE Auditor or Quality Manager. Assisting the Quality Manager with the achievement of annual objectives as directed. Collate and trend quality metrics and suggest improvement activities as required. Support and assist third party audits and inspections across Eakin Healthcare as required. Assist with ensuring the QMS reflects practice and is kept up to date in line with requirements. In conjunction with other departments, ensure all reported Customer Complaints are acknowledged, investigated, and reported within Target Closure timelines; and ensure all stability studies are documented, actioned, and reported. Collaborate and own Corrective and Preventative Actions, Customer Complaints, Non- Conformances, and subsequent product dispositions e.g. product rework administration. Maintain the Calibration Support the change control system by accurate completion of documentation and realising any relevant actions. Ensure product quality standards are met by implementing inspection and testing protocols on products within all production, goods in and warehousing areas Ensure inspections are performed in compliance with QMS documentation and that the inspections are being recorded accurately Develop a high level of understanding of the safety and functional aspects of each product type Report all Quality related issues to the Quality Manager Carry out product segregation and quarantine actions when necessary. Ensure testing requirements are met at all stages of the production process and that appropriate documentation is Ensure accurate records of any inspection and test activity are completed and forwarded to the Quality Manager for review against specified targets. Develop a thorough knowledge of the Operating Procedures, Work Instructions and Quality Forms relevant to the various Production areas and Goods In. Assist the Quality department with Quality System/Product development administration tasks as Provide accurate data relating to inspection levels for analysis by the Quality Manager. Demonstrate best production assembly techniques and hygiene practices and be able to lead and train production operatives by example. Be able to clearly define pass/fail criteria to Production staff, providing guidance on Quality issues without impacting negatively on the work efficiency of staff. Assist the Quality Manager to review the effectiveness of preventive actions taken in response to product quality issues raised. Other To adhere to the company's Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible. To be responsible for your own health and safety and that of your colleagues, in accordance with the company's' Health and Safety policy. To adhere to the company's Quality policy and Environmental policy. To undertake other duties as may be reasonably required. WHAT WE'RE LOOKING FOR Minimum of 5 GCSEs or equivalent, including Math and English and/or several years' experience within in a medical device manufacturing environment. Experience in a regulated manufacturing environment with involvement in Quality-related activities, and an understanding of recognised quality standards and compliance requirements Strong interpersonal and communication skills. Able to quickly build effective professional working relationships. Meticulous with high levels of attention to detail. Strong command of written English. Excellent organisational and planning skills to deliver efficient QMS based outputs. Proactive and able to work unsupervised. Ability to work well in a team. Competent in the use of Microsoft office Experience of working in a product/batch release role in the medical device/pharmaceutical industry. Experience of working in a regulated manufacturing environment (e.g., ISO13485, ISO14971, MDD, EU MDR, MDSAP). Experience of using an electronic quality management system (eQMS). Experience in good documentation practices (GDP). Experience in a medical device / life sciences environment. Experience of using problem solving and root cause analysis tools (8D, FMEA etc.). Experience in implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions arising from product/process/customer complaint/audit issues. Experience in development of training materials and delivery of training presentations. Quality auditing certification. Methodical with analytical and problem-solving ADDITIONAL INFORMATION Occasional travel as & when required to other Eakin Healthcare sites.
Nov 02, 2025
Full time
At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. We've been recognised as a Great Place to Work ! And we're proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women. At Eakin Healthcare, we're united by one mission: working together to improve lives - just like we've been doing for over five decades. WHY JOIN US? We're good at what we do - come and join us and you can benefit from: Blended Working Bonus 25 days holiday plus bank holidays (rising to 28) Option to buy holiday days Health Cash Plan Pension Life Assurance Enhanced Maternity/Paternity Cycle to Work Scheme Referral Scheme Long Service Awards Free Parking ABOUT THE ROLE A member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a key role in the Operations Compliance Team, provide business support and guidance in line with Compliance and Eakin Healthcare Strategies. This role in based in Coleraine, Northern Ireland and is an excellent opportunity for an individual to work closely with both site-based functions and colleagues and wider group colleagues in the Group Operations Compliance Team. KEY RESPONSIBILITIES Involved in the creation, improvement and maintenance of regulatory compliant Quality Management System (QMS) documentation (and training thereof) that will include, but not be limited to: QMS reports and analysis of reports for review by the Quality Manager. Quality reports for review at Management Review meetings. Reviewing and actioning feedback from customers. Support creation, revision and maintenance of Operating Procedures, Quality Forms and Work Instructions. Support QMS studies and reports e.g. stability studies. Identification, investigation and documentation of product and process non-conformances document root cause and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements. Support and execute the timely release of finished medical devices to ensure schedules are maintained and stock available. Support and co-ordinate the accurate completion, retention, and review of product release documentation, liaising where necessary with the relevant internal stakeholders and ensuring all product release documentation complies with the appropriate site regulatory certification and standards (ISO13485, MDSAP, GMP, GDP, FDA CFR). Inform and collate quality feedback data ensuring that key information is relayed to the Quality Manager. Support and perform internal audits under guidance from the QHSE Auditor or Quality Manager. Assisting the Quality Manager with the achievement of annual objectives as directed. Collate and trend quality metrics and suggest improvement activities as required. Support and assist third party audits and inspections across Eakin Healthcare as required. Assist with ensuring the QMS reflects practice and is kept up to date in line with requirements. In conjunction with other departments, ensure all reported Customer Complaints are acknowledged, investigated, and reported within Target Closure timelines; and ensure all stability studies are documented, actioned, and reported. Collaborate and own Corrective and Preventative Actions, Customer Complaints, Non- Conformances, and subsequent product dispositions e.g. product rework administration. Maintain the Calibration Support the change control system by accurate completion of documentation and realising any relevant actions. Ensure product quality standards are met by implementing inspection and testing protocols on products within all production, goods in and warehousing areas Ensure inspections are performed in compliance with QMS documentation and that the inspections are being recorded accurately Develop a high level of understanding of the safety and functional aspects of each product type Report all Quality related issues to the Quality Manager Carry out product segregation and quarantine actions when necessary. Ensure testing requirements are met at all stages of the production process and that appropriate documentation is Ensure accurate records of any inspection and test activity are completed and forwarded to the Quality Manager for review against specified targets. Develop a thorough knowledge of the Operating Procedures, Work Instructions and Quality Forms relevant to the various Production areas and Goods In. Assist the Quality department with Quality System/Product development administration tasks as Provide accurate data relating to inspection levels for analysis by the Quality Manager. Demonstrate best production assembly techniques and hygiene practices and be able to lead and train production operatives by example. Be able to clearly define pass/fail criteria to Production staff, providing guidance on Quality issues without impacting negatively on the work efficiency of staff. Assist the Quality Manager to review the effectiveness of preventive actions taken in response to product quality issues raised. Other To adhere to the company's Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible. To be responsible for your own health and safety and that of your colleagues, in accordance with the company's' Health and Safety policy. To adhere to the company's Quality policy and Environmental policy. To undertake other duties as may be reasonably required. WHAT WE'RE LOOKING FOR Minimum of 5 GCSEs or equivalent, including Math and English and/or several years' experience within in a medical device manufacturing environment. Experience in a regulated manufacturing environment with involvement in Quality-related activities, and an understanding of recognised quality standards and compliance requirements Strong interpersonal and communication skills. Able to quickly build effective professional working relationships. Meticulous with high levels of attention to detail. Strong command of written English. Excellent organisational and planning skills to deliver efficient QMS based outputs. Proactive and able to work unsupervised. Ability to work well in a team. Competent in the use of Microsoft office Experience of working in a product/batch release role in the medical device/pharmaceutical industry. Experience of working in a regulated manufacturing environment (e.g., ISO13485, ISO14971, MDD, EU MDR, MDSAP). Experience of using an electronic quality management system (eQMS). Experience in good documentation practices (GDP). Experience in a medical device / life sciences environment. Experience of using problem solving and root cause analysis tools (8D, FMEA etc.). Experience in implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions arising from product/process/customer complaint/audit issues. Experience in development of training materials and delivery of training presentations. Quality auditing certification. Methodical with analytical and problem-solving ADDITIONAL INFORMATION Occasional travel as & when required to other Eakin Healthcare sites.
ARC Regulatory is seeking a dynamic Head of Product Development - IVD to lead the transition of diagnostic products from Research Use Only (RUO) to Investigational Use Only (IUO). This senior role offers the opportunity to shape product strategy, drive assay development, and manage cross-functional initiatives with Regulatory, Clinical, QA, and Lab teams. Key Responsibilities Lead end-to-end IVD development from RUO to IUO. Define product roadmaps and oversee assay design, validation, and tech transfer. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, and ISO 14971. Inspire cross-functional teams and collaborate with internal and external stakeholders. Oversee project timelines, budgets, and regulatory readiness for clinical trials. Qualifications PhD/MSc in Biological Sciences or related field. 5+ years in IVD or life sciences product development. Proven experience in regulatory and clinical readiness for IVD products. Strong knowledge of design control, quality systems, and assay validation. Preferred Experience with companion diagnostics or LDT strategies. Familiarity with digital health or SaMD.
Oct 31, 2025
Full time
ARC Regulatory is seeking a dynamic Head of Product Development - IVD to lead the transition of diagnostic products from Research Use Only (RUO) to Investigational Use Only (IUO). This senior role offers the opportunity to shape product strategy, drive assay development, and manage cross-functional initiatives with Regulatory, Clinical, QA, and Lab teams. Key Responsibilities Lead end-to-end IVD development from RUO to IUO. Define product roadmaps and oversee assay design, validation, and tech transfer. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, and ISO 14971. Inspire cross-functional teams and collaborate with internal and external stakeholders. Oversee project timelines, budgets, and regulatory readiness for clinical trials. Qualifications PhD/MSc in Biological Sciences or related field. 5+ years in IVD or life sciences product development. Proven experience in regulatory and clinical readiness for IVD products. Strong knowledge of design control, quality systems, and assay validation. Preferred Experience with companion diagnostics or LDT strategies. Familiarity with digital health or SaMD.
AsDigitalMarketingExecutive, you willbe responsible fordelivering the day-to-day marketing activities that support ARCs globalserviceportfolio.Youwill helpdevelop &execute campaigns across multiplecommunications,generate leads,providesalessupportand strengthen ARCs reputation as the gold-standard IVD andCDxresearch solutions provider to the global precision medicine and in vitro diagnostics sectors. Key Responsibilities Help deliver and executemarketing campaigns across digital, social, email and print, ensuring alignment with brand guidelines. Support the SalesTeam by generating MarketingQualifiedLeads(MQLs) to create a strong pipeline of potential customers Liaise with third-partyvendors,external agencies, CRM contractors, and designers. Create andmaintainengagingcontent for ARCs website, newsletters, and social channelsalongsidecontributing to the overall digital transformation of the company Assistin managing ARCs professional social media accounts and support delivery of the companys social media strategy. Coordinate ARCs participation in industry events, includinglogistics, promotional materials, and on-site support. Support the adaptation and implementation of AI tools within the CRM to enhance lead management, customer insights, and marketing efficiency. Support the effective use and day-to-day management of HubSpot CRM, including campaign tracking and reporting. Assistwithwebinarcoordination, including promotion, execution, and post-event follow-up. Conduct competitor research and market scanning toidentifyopportunities. Track and report on campaign performance using HubSpot, Google Analytics, and LinkedIn insights. Undertake professional development to stay current with marketing best practice and digital tools. Contribute to ARC company culture and support broader Commercial team initiatives. Essential Criteria & Qualifications Degree in Marketing, Communications, Business, or a related field. 3-5 yearsmarketing experience, ideally in a B2B or life sciences environment. Experience creating on-brand digital content. Experience managing or working with CRM systems (HubSpot desirable) Familiarity with CMS platforms (e.g., WordPress) for website updates. Strong understanding of social media management tools Analytical mindset with ability to interpret marketing data. Experience in Adobe Creative Suite or Canva Knowledge of precision medicine, IVD or broader life sciences industry. Email marketing and automation knowledge. Application of Automation and Artificial Intelligence as part of ERP implementation.
Oct 29, 2025
Full time
AsDigitalMarketingExecutive, you willbe responsible fordelivering the day-to-day marketing activities that support ARCs globalserviceportfolio.Youwill helpdevelop &execute campaigns across multiplecommunications,generate leads,providesalessupportand strengthen ARCs reputation as the gold-standard IVD andCDxresearch solutions provider to the global precision medicine and in vitro diagnostics sectors. Key Responsibilities Help deliver and executemarketing campaigns across digital, social, email and print, ensuring alignment with brand guidelines. Support the SalesTeam by generating MarketingQualifiedLeads(MQLs) to create a strong pipeline of potential customers Liaise with third-partyvendors,external agencies, CRM contractors, and designers. Create andmaintainengagingcontent for ARCs website, newsletters, and social channelsalongsidecontributing to the overall digital transformation of the company Assistin managing ARCs professional social media accounts and support delivery of the companys social media strategy. Coordinate ARCs participation in industry events, includinglogistics, promotional materials, and on-site support. Support the adaptation and implementation of AI tools within the CRM to enhance lead management, customer insights, and marketing efficiency. Support the effective use and day-to-day management of HubSpot CRM, including campaign tracking and reporting. Assistwithwebinarcoordination, including promotion, execution, and post-event follow-up. Conduct competitor research and market scanning toidentifyopportunities. Track and report on campaign performance using HubSpot, Google Analytics, and LinkedIn insights. Undertake professional development to stay current with marketing best practice and digital tools. Contribute to ARC company culture and support broader Commercial team initiatives. Essential Criteria & Qualifications Degree in Marketing, Communications, Business, or a related field. 3-5 yearsmarketing experience, ideally in a B2B or life sciences environment. Experience creating on-brand digital content. Experience managing or working with CRM systems (HubSpot desirable) Familiarity with CMS platforms (e.g., WordPress) for website updates. Strong understanding of social media management tools Analytical mindset with ability to interpret marketing data. Experience in Adobe Creative Suite or Canva Knowledge of precision medicine, IVD or broader life sciences industry. Email marketing and automation knowledge. Application of Automation and Artificial Intelligence as part of ERP implementation.
Head of Product Development - In Vitro Diagnostics ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients. We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial. ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable. To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials. ARC Regulatory is seeking a dynamic Head of Product Development - IVD to lead the transition of diagnostic products from Research Use Only (RUO) to Investigational Use Only (IUO). This senior role offers the opportunity to shape product strategy, drive assay development, and manage cross-functional initiatives with Regulatory, Clinical, QA, and Lab teams. Key Responsibilities Lead end-to-end IVD development from RUO to IUO. Define product roadmaps and oversee assay design, validation, and tech transfer. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, and ISO 14971. Inspire cross-functional teams and collaborate with internal and external stakeholders. Oversee project timelines, budgets, and regulatory readiness for clinical trials. Qualifications PhD/MSc in Biological Sciences or related field. 5+ years in IVD or life sciences product development. Proven experience in regulatory and clinical readiness for IVD products. Strong knowledge of design control, quality systems, and assay validation. Preferred Experience with companion diagnostics or LDT strategies. Familiarity with digital health or SaMD.
Oct 24, 2025
Full time
Head of Product Development - In Vitro Diagnostics ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients. We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial. ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable. To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials. ARC Regulatory is seeking a dynamic Head of Product Development - IVD to lead the transition of diagnostic products from Research Use Only (RUO) to Investigational Use Only (IUO). This senior role offers the opportunity to shape product strategy, drive assay development, and manage cross-functional initiatives with Regulatory, Clinical, QA, and Lab teams. Key Responsibilities Lead end-to-end IVD development from RUO to IUO. Define product roadmaps and oversee assay design, validation, and tech transfer. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, and ISO 14971. Inspire cross-functional teams and collaborate with internal and external stakeholders. Oversee project timelines, budgets, and regulatory readiness for clinical trials. Qualifications PhD/MSc in Biological Sciences or related field. 5+ years in IVD or life sciences product development. Proven experience in regulatory and clinical readiness for IVD products. Strong knowledge of design control, quality systems, and assay validation. Preferred Experience with companion diagnostics or LDT strategies. Familiarity with digital health or SaMD.
Life Science Project Manager - Junior Consultant, Senior Consultant We are seeking an experienced Project Manager to join our growing Life Sciences Advisory team. With 3-4 years of relevant project management experience, you will lead and support the successful delivery of Life Sciences consulting projects. In this role, you will collaborate closely with our Life Sciences consultants and client stakeholders to manage project execution, ensure adherence to timelines, budgets, and scope, and drive innovative solutions for our clients in the Life Sciences sector. As a key member of the team, you will also contribute to business development and client relationship management while mentoring junior team members. The role offers a chance to contribute to and support a variety of client engagements across our Life Sciences portfolio. We are particularly interested in candidates with experience in the pharmaceutical, biotechnology or medical device industries although this is not essential. A general knowledge or familiarity with industry systems (e.g. ERP, MES etc.), and Agile project management experience would be advantageous, though not essential, while experience in various areas of the life sciences industry (e.g. PMO, regulatory affairs, operational excellence, R&D, market access, or other) would also be beneficial. Embrace the possibility to apply - at Grant Thornton we are constantly upskilling our staff. If you do not meet all of the listed requirements, please do not be discouraged from applying. We value a growth-oriented mindset and are dedicated to supporting you in reaching your full potential. As a Project Manager in the Life Sciences Advisory team, you will play a key role in managing client projects and supporting colleagues in delivering tailored solutions. With 3-4 years of relevant experience, you will be expected to take ownership of project execution, ensuring the successful delivery of projects. Key Responsibilities: Lead and Support Project Execution: Collaborate with team members and stakeholders to manage and execute the delivery of complex projects for key clients across the Life Sciences industry. Client Engagement and Relationship Management: Serve as a point of contact for clients, assisting in communication, addressing project-related queries, and fostering strong client relationships to ensure high-quality project delivery. Research and Analysis: Conduct in-depth research and data analysis to support the development of strategic solutions for clients. This includes analysing sector trends, industry regulations, and operational data. Develop and Deliver Client Solutions: Contribute to the development and delivery of innovative solutions, collaborating with senior consultants to create actionable recommendations and strategies tailored to each client. Prepare Reports and Presentations: Develop high-quality presentations, reports, and deliverables that clearly communicate project findings, insights, and recommendations to clients and senior stakeholders. Contribute to Business Growth: Assist in the preparation of proposals and tender documentation, business development activities, and marketing initiatives to support the growth of the consulting practice. Risk and Issue Management: Identify and manage project risks and issues, escalating them as necessary, and working with the team to develop mitigation strategies. Preparing comprehensive project documentation including, but not limited to, Project Plans, Reports, RAID Logs, Status Updates etc. Team Collaboration and Leadership: Work closely with cross-functional teams to ensure project objectives are met. Mentor and guide junior team members, offering advice and support as needed. Stay Current with Life Sciences Industry Trends: Continuously monitor developments in the life sciences sector, including regulatory changes, market shifts, and new technologies. Share relevant insights with the team to inform project strategies. Professional Development and Training: Participate in ongoing professional development activities to enhance expertise in Life Sciences consulting and project management methodologies. Skills and Experience Education and Certifications A third-level degree, with a strong academic record. Project Management certification, with a demonstrated ability to apply best practices, tools and methodologies (e.g., PRINCE2, Agile, or tailored approaches) to deliver measurable project outcomes. Minimum of 3years of relevant professional experience depending on the level being applied for. Skills and Competencies Project/Programme Management Experience: Proven experience in successfully delivering high-quality life sciences-related projects, ideally within a consulting firm or professional services environment. Prior exposure to life sciences advisory services is highly desirable. End-to-End Project Delivery: Demonstrated ability to manage and oversee projects through all stages of the project lifecycle, from initiation to closure, ensuring successful outcomes within scope, timeline, and budget. Strong Analytical and Interpersonal Skills: Excellent analytical capabilities with the ability to assess complex data and provide actionable insights. Skilled in building and maintaining effective relationships with clients and stakeholders to ensure seamless collaboration. Multi-Tasking and Deadline Management: Ability to manage multiple priorities simultaneously while ensuring deadlines are met in a fast-paced, dynamic environment. Effective Communication Skills: Exceptional written and verbal communication skills, including the ability to engage with senior stakeholders, clients, and team members. Experience in preparing clear, concise reports, presentations, and tender documents. Time Management and Prioritisation: Strong organisational skills with the ability to prioritise tasks effectively, ensuring that critical deadlines are met without compromising quality. Attention to Detail: A keen eye for detail, ensuring that all aspects of project deliverables and communications are accurate and thorough. Big-Picture and Detail-Oriented Thinking: Ability to balance strategic, high-level thinking with a focus on granular details, ensuring both vision and execution are aligned with client expectations. Curiosity and Business Development: A proactive, inquisitive mindset with a natural curiosity to explore new business opportunities and contribute to the growth of the consulting practice. Problem-Solving and Initiative: Self-motivated, solution-focused approach with the ability to identify challenges and implement effective solutions independently, driving continuous improvement and innovation. Ability to work independently and as part of a team.
Oct 24, 2025
Full time
Life Science Project Manager - Junior Consultant, Senior Consultant We are seeking an experienced Project Manager to join our growing Life Sciences Advisory team. With 3-4 years of relevant project management experience, you will lead and support the successful delivery of Life Sciences consulting projects. In this role, you will collaborate closely with our Life Sciences consultants and client stakeholders to manage project execution, ensure adherence to timelines, budgets, and scope, and drive innovative solutions for our clients in the Life Sciences sector. As a key member of the team, you will also contribute to business development and client relationship management while mentoring junior team members. The role offers a chance to contribute to and support a variety of client engagements across our Life Sciences portfolio. We are particularly interested in candidates with experience in the pharmaceutical, biotechnology or medical device industries although this is not essential. A general knowledge or familiarity with industry systems (e.g. ERP, MES etc.), and Agile project management experience would be advantageous, though not essential, while experience in various areas of the life sciences industry (e.g. PMO, regulatory affairs, operational excellence, R&D, market access, or other) would also be beneficial. Embrace the possibility to apply - at Grant Thornton we are constantly upskilling our staff. If you do not meet all of the listed requirements, please do not be discouraged from applying. We value a growth-oriented mindset and are dedicated to supporting you in reaching your full potential. As a Project Manager in the Life Sciences Advisory team, you will play a key role in managing client projects and supporting colleagues in delivering tailored solutions. With 3-4 years of relevant experience, you will be expected to take ownership of project execution, ensuring the successful delivery of projects. Key Responsibilities: Lead and Support Project Execution: Collaborate with team members and stakeholders to manage and execute the delivery of complex projects for key clients across the Life Sciences industry. Client Engagement and Relationship Management: Serve as a point of contact for clients, assisting in communication, addressing project-related queries, and fostering strong client relationships to ensure high-quality project delivery. Research and Analysis: Conduct in-depth research and data analysis to support the development of strategic solutions for clients. This includes analysing sector trends, industry regulations, and operational data. Develop and Deliver Client Solutions: Contribute to the development and delivery of innovative solutions, collaborating with senior consultants to create actionable recommendations and strategies tailored to each client. Prepare Reports and Presentations: Develop high-quality presentations, reports, and deliverables that clearly communicate project findings, insights, and recommendations to clients and senior stakeholders. Contribute to Business Growth: Assist in the preparation of proposals and tender documentation, business development activities, and marketing initiatives to support the growth of the consulting practice. Risk and Issue Management: Identify and manage project risks and issues, escalating them as necessary, and working with the team to develop mitigation strategies. Preparing comprehensive project documentation including, but not limited to, Project Plans, Reports, RAID Logs, Status Updates etc. Team Collaboration and Leadership: Work closely with cross-functional teams to ensure project objectives are met. Mentor and guide junior team members, offering advice and support as needed. Stay Current with Life Sciences Industry Trends: Continuously monitor developments in the life sciences sector, including regulatory changes, market shifts, and new technologies. Share relevant insights with the team to inform project strategies. Professional Development and Training: Participate in ongoing professional development activities to enhance expertise in Life Sciences consulting and project management methodologies. Skills and Experience Education and Certifications A third-level degree, with a strong academic record. Project Management certification, with a demonstrated ability to apply best practices, tools and methodologies (e.g., PRINCE2, Agile, or tailored approaches) to deliver measurable project outcomes. Minimum of 3years of relevant professional experience depending on the level being applied for. Skills and Competencies Project/Programme Management Experience: Proven experience in successfully delivering high-quality life sciences-related projects, ideally within a consulting firm or professional services environment. Prior exposure to life sciences advisory services is highly desirable. End-to-End Project Delivery: Demonstrated ability to manage and oversee projects through all stages of the project lifecycle, from initiation to closure, ensuring successful outcomes within scope, timeline, and budget. Strong Analytical and Interpersonal Skills: Excellent analytical capabilities with the ability to assess complex data and provide actionable insights. Skilled in building and maintaining effective relationships with clients and stakeholders to ensure seamless collaboration. Multi-Tasking and Deadline Management: Ability to manage multiple priorities simultaneously while ensuring deadlines are met in a fast-paced, dynamic environment. Effective Communication Skills: Exceptional written and verbal communication skills, including the ability to engage with senior stakeholders, clients, and team members. Experience in preparing clear, concise reports, presentations, and tender documents. Time Management and Prioritisation: Strong organisational skills with the ability to prioritise tasks effectively, ensuring that critical deadlines are met without compromising quality. Attention to Detail: A keen eye for detail, ensuring that all aspects of project deliverables and communications are accurate and thorough. Big-Picture and Detail-Oriented Thinking: Ability to balance strategic, high-level thinking with a focus on granular details, ensuring both vision and execution are aligned with client expectations. Curiosity and Business Development: A proactive, inquisitive mindset with a natural curiosity to explore new business opportunities and contribute to the growth of the consulting practice. Problem-Solving and Initiative: Self-motivated, solution-focused approach with the ability to identify challenges and implement effective solutions independently, driving continuous improvement and innovation. Ability to work independently and as part of a team.
QUBIS is the commercialisation and investment arm of Queen's University Belfast, a research-intensive University and a member of the Russell Group. QUBIS is a private limited company that plays a very prominent role in the delivery of pipeline discovery science through to commercialisation. It has created over 100 spin-out companies, secured £155m in venture capital investment into Northern Ireland, and is the 3rd most active seed investor in the region. Queen's is the leading university in the UK for Entrepreneurial Impact based on production of IP, creation of spin-outs, and portfolio realisations, relative to research funding. QUBIS is expanding its innovation programme offering to support student and graduate enterprise, with the Student Launch pre-accelerator and a Graduate Launch accelerator. QUBIS now seeks to appoint a Chief Executive Officer to drive commercialisation of research outputs, drive innovation and entrepreneurship and provide strategic leadership to further develop the organisation. Reporting to the Chair of the Board, the Chief Executive Officer is responsible for the overall strategic direction and execution of QUBIS's mission. The post holder will foster innovation and entrepreneurship in Northern Ireland and execute the business of the Company on behalf of the QUBIS Board as detailed in the approved strategic and annual business plans. They will also maximise impact and commercial success by building and cultivating strategic relationships with key stakeholders and work with academic founders to realise commercialisation opportunities for Queen's. The successful candidate will be a strategic leader with experience working in a university commercialisation context or similar innovation-led environment within the deep tech sector and can demonstrate success in commercialising academic research, managing early-stage investment models, and driving portfolio growth. The role requires an effective and motivational leader, experienced in building high-performing teams and engaging a wide range of internal and external stakeholders. In addition, they will have a sharp commercial instinct and experience in IP rights, licensing, and joint ventures to maximise commercial impact.
Oct 12, 2025
Full time
QUBIS is the commercialisation and investment arm of Queen's University Belfast, a research-intensive University and a member of the Russell Group. QUBIS is a private limited company that plays a very prominent role in the delivery of pipeline discovery science through to commercialisation. It has created over 100 spin-out companies, secured £155m in venture capital investment into Northern Ireland, and is the 3rd most active seed investor in the region. Queen's is the leading university in the UK for Entrepreneurial Impact based on production of IP, creation of spin-outs, and portfolio realisations, relative to research funding. QUBIS is expanding its innovation programme offering to support student and graduate enterprise, with the Student Launch pre-accelerator and a Graduate Launch accelerator. QUBIS now seeks to appoint a Chief Executive Officer to drive commercialisation of research outputs, drive innovation and entrepreneurship and provide strategic leadership to further develop the organisation. Reporting to the Chair of the Board, the Chief Executive Officer is responsible for the overall strategic direction and execution of QUBIS's mission. The post holder will foster innovation and entrepreneurship in Northern Ireland and execute the business of the Company on behalf of the QUBIS Board as detailed in the approved strategic and annual business plans. They will also maximise impact and commercial success by building and cultivating strategic relationships with key stakeholders and work with academic founders to realise commercialisation opportunities for Queen's. The successful candidate will be a strategic leader with experience working in a university commercialisation context or similar innovation-led environment within the deep tech sector and can demonstrate success in commercialising academic research, managing early-stage investment models, and driving portfolio growth. The role requires an effective and motivational leader, experienced in building high-performing teams and engaging a wide range of internal and external stakeholders. In addition, they will have a sharp commercial instinct and experience in IP rights, licensing, and joint ventures to maximise commercial impact.