Oxford Gene Technology
Cambridge, Cambridgeshire
OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines. An opportunity has arisen in our Cambridge based Regulatory and Medical Affairs team for a Regulatory Affairs Manager. Our Regulatory and Medical Affairs team is responsible for ensuring that OGT's products are safe, effective, and fit for purpose, thus allowing them to be available globally and state of the art. This role requires the post-holder to take operational responsibility for the creation and implementation of OGT regulatory strategies, and accountability for the delivery of regulatory tasks by members of their team. The role has many facets, from pre-market to post-market, and includes oversight of vigilance and product recall activities, as well as driving the regulatory strategy for new/updated product development. What you'll be doing for us Maintain knowledge of the Company's portfolio with respect to the technical and scientific environment, clinical purpose, and regulatory framework. Proactively plan, manage and drive the regulatory strategy, submission and approval requirements for new product developments and product/manufacturing changes, leading developmental teams on regulatory requirements. Liaise effectively with product managers, product development team managers, operations managers, and other stakeholders to ensure timely completion of tasks in support of regulatory submissions. Act as Subject Matter Expert (SME) and Regulatory Affairs (RA) lead for the product development projects, providing "solution-based" advice to development teams. Update on the progress of registration processes and other RA group activities to line management or project teams when requested. To identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs. Accountable to the EVP for upkeep of submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information. Work with internal and external stakeholders to review and approve labelling, advertising, and promotional items to ensure regulatory compliance. Manage interactions with authorised representatives, distributors, 3 rd parties and international regulatory agencies and provide supporting documentation, handle queries issues and complaints. Liaise with product managers and other key stakeholders to maintain product technical documentation and records supporting the Quality Management System (QMS). Accountable for the delivery of risk management processes; ensure risk management files are developed, followed, and implemented. Accountable for the delivery of post market surveillance activities. Accountable for the delivery of procedures for dealing with products that require corrective action and reporting (vigilance), ensuring the appropriate activities are completed within required timelines. Manage and develop periodical reviews of worldwide regulatory framework for existing and new markets, liaise with key stakeholders to maintain QMS processes and submission of documentation for the continuing compliance of the Company's portfolio. In conjunction with appropriate stake holders, approve the regulatory impact of product changes. Develop regulatory submission strategies to facilitate the timely commercialisation of new or modified products in global markets. Where appropriate, review and approve technical documentation, risk analysis, performance evaluation studies, and other documentation for submission filing. Accountable for ensuring correct documentation is generated to appropriate standards. Review and approve risk management documentation. Manage, and report where required, safety officer responsibilities including the use of Trackwise. To complete any other tasks as commensurate with the level and nature of the post as delegated by the EVP. Review the impact of changes to standards and legislation and help manage any required conformance and change activities. Report any impacts to EVP. Monitor pending regulatory submissions, registration process or other RA group activities to ensure timely delivery. Communicate to management any identified delays that may impact business expectations. To interact with regulatory consultants, regulatory and trade associations and other third-party service providers to ensure their provision of any requested activities to agreed timescales. To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices Supply reports, reviews, or summaries of KPIs to the OGT Executive team as required. Subject to possession of the required qualifications, and if so designated in the Company's Strategy for Regulatory Compliance and/or Organisation Chart, to act as the/a Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of the European IVD Regulation (EU) 2017/746. Play an active role in engagement/leadership/people management activities within the RA department. Advising on and reviewing company structure to ensure efficiencies, working to a budget. Manage and implement training programmes for junior employees. What we are looking for in you Degree level education or equivalent, in life sciences Holds a recognised qualification in Regulatory Affairs Evidence of CPD Experience of working to ISO 13485 Ability to independently-manage multiple projects, department initiatives, and day-to-day tasks. Experience in post market surveillance activities, vigilance and recall activities Experience of dealing with Competent Authorities, global regulators and notified bodies. In return you will receive: Private Health Insurance Group Income Protection Group Life Assurance High Street Discount Scheme. Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period. Please note that we will need to establish your right to work during the recruitment process. Create a Job Alert Interested in building your career at OGT? Get future opportunities sent straight to your email. Apply for this job indicates a required field First Name Last Name Email Phone Resume/CV Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Please confirm you have the right to work in the UK.Please note, we are unable to sponsor any visa applications at this time and applicants must have the right to work in the UK. Select
OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines. An opportunity has arisen in our Cambridge based Regulatory and Medical Affairs team for a Regulatory Affairs Manager. Our Regulatory and Medical Affairs team is responsible for ensuring that OGT's products are safe, effective, and fit for purpose, thus allowing them to be available globally and state of the art. This role requires the post-holder to take operational responsibility for the creation and implementation of OGT regulatory strategies, and accountability for the delivery of regulatory tasks by members of their team. The role has many facets, from pre-market to post-market, and includes oversight of vigilance and product recall activities, as well as driving the regulatory strategy for new/updated product development. What you'll be doing for us Maintain knowledge of the Company's portfolio with respect to the technical and scientific environment, clinical purpose, and regulatory framework. Proactively plan, manage and drive the regulatory strategy, submission and approval requirements for new product developments and product/manufacturing changes, leading developmental teams on regulatory requirements. Liaise effectively with product managers, product development team managers, operations managers, and other stakeholders to ensure timely completion of tasks in support of regulatory submissions. Act as Subject Matter Expert (SME) and Regulatory Affairs (RA) lead for the product development projects, providing "solution-based" advice to development teams. Update on the progress of registration processes and other RA group activities to line management or project teams when requested. To identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs. Accountable to the EVP for upkeep of submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information. Work with internal and external stakeholders to review and approve labelling, advertising, and promotional items to ensure regulatory compliance. Manage interactions with authorised representatives, distributors, 3 rd parties and international regulatory agencies and provide supporting documentation, handle queries issues and complaints. Liaise with product managers and other key stakeholders to maintain product technical documentation and records supporting the Quality Management System (QMS). Accountable for the delivery of risk management processes; ensure risk management files are developed, followed, and implemented. Accountable for the delivery of post market surveillance activities. Accountable for the delivery of procedures for dealing with products that require corrective action and reporting (vigilance), ensuring the appropriate activities are completed within required timelines. Manage and develop periodical reviews of worldwide regulatory framework for existing and new markets, liaise with key stakeholders to maintain QMS processes and submission of documentation for the continuing compliance of the Company's portfolio. In conjunction with appropriate stake holders, approve the regulatory impact of product changes. Develop regulatory submission strategies to facilitate the timely commercialisation of new or modified products in global markets. Where appropriate, review and approve technical documentation, risk analysis, performance evaluation studies, and other documentation for submission filing. Accountable for ensuring correct documentation is generated to appropriate standards. Review and approve risk management documentation. Manage, and report where required, safety officer responsibilities including the use of Trackwise. To complete any other tasks as commensurate with the level and nature of the post as delegated by the EVP. Review the impact of changes to standards and legislation and help manage any required conformance and change activities. Report any impacts to EVP. Monitor pending regulatory submissions, registration process or other RA group activities to ensure timely delivery. Communicate to management any identified delays that may impact business expectations. To interact with regulatory consultants, regulatory and trade associations and other third-party service providers to ensure their provision of any requested activities to agreed timescales. To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices Supply reports, reviews, or summaries of KPIs to the OGT Executive team as required. Subject to possession of the required qualifications, and if so designated in the Company's Strategy for Regulatory Compliance and/or Organisation Chart, to act as the/a Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of the European IVD Regulation (EU) 2017/746. Play an active role in engagement/leadership/people management activities within the RA department. Advising on and reviewing company structure to ensure efficiencies, working to a budget. Manage and implement training programmes for junior employees. What we are looking for in you Degree level education or equivalent, in life sciences Holds a recognised qualification in Regulatory Affairs Evidence of CPD Experience of working to ISO 13485 Ability to independently-manage multiple projects, department initiatives, and day-to-day tasks. Experience in post market surveillance activities, vigilance and recall activities Experience of dealing with Competent Authorities, global regulators and notified bodies. In return you will receive: Private Health Insurance Group Income Protection Group Life Assurance High Street Discount Scheme. Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period. Please note that we will need to establish your right to work during the recruitment process. Create a Job Alert Interested in building your career at OGT? Get future opportunities sent straight to your email. Apply for this job indicates a required field First Name Last Name Email Phone Resume/CV Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Please confirm you have the right to work in the UK.Please note, we are unable to sponsor any visa applications at this time and applicants must have the right to work in the UK. Select
The Francis Crick Institute
BRF Animal Technician Details of the role: Full time, permanent 36 hours Part-time opportunities may also be available, please note any preferred working pattern in your application. About us The Francis Crick Institute is Europe s largest biomedical research institute under one roof. Our world-class scientists and staff collaborate on vital research to help prevent, diagnose and treat illnesses such as cancer, heart disease, infectious diseases and neurodegenerative conditions. The Biological Research Facility is the Crick s animal facility offering services to those researchers who use animals such as mice and fish to answer their research questions. For example, studying the effects of genes on development, or identifying the molecules involved in how cancer spreads. The Biological Research Facility supports all animal research at the Crick through its comprehensive animal care and use programme, and provides the Crick's laboratory animal resource and technical services. There are approximately 150 animal care staff spread across several self-contained animal units. High quality multidisciplinary experimental outcomes are at the heart of the BRF's philosophy and operations, delivered to the highest of animal welfare standards. The BRF teams integrate husbandry of multiple species within a range of facilities, using state of the art technologies, via a talented and skilled team. About the role This role is ideal for anyone who s passionate about working with animals, dedicated to animal welfare, and enjoys hands-on, practical work. If you re excited by the idea of creating the best possible environment for animals in a research setting, while directly contributing to world-leading scientific discoveries, the Francis Crick Institute could be the perfect place to build a meaningful career in Animal Technology. We re looking for enthusiastic, self-motivated team players to join us as Animal Technicians, key members of our organisation who play a vital role in enhancing the quality of life for our laboratory animals. You ll work within our state-of-the-art animal facility, carrying out husbandry duties and supporting the full breadth of research at the Crick through our comprehensive animal care and use programme. At the Francis Crick Institute, we re committed to helping you grow. We provide thorough training and ongoing support so you can build a rewarding career where your work makes a real difference to both research and animal welfare. Whether you re seeking a new challenge or taking the next step in your career, this could be the opportunity you ve been looking for. As a new technician, you ll learn all aspects of animal husbandry, gain experience using our record-keeping systems, and develop a solid understanding of the legal frameworks that guide our work. You ll also complete the IAT Level 2 qualification and have the chance to obtain a Home Office Personal Licence. Our BRF Research Officer roles open the door to long-term growth, continuous learning, and clear career progression, making this a fantastic pathway for anyone looking to develop their skills and build a future in Animal Technology. What you will be doing As an Animal Technician at the Crick, you will: Provide excellent care, welfare and husbandry to laboratory animals Clean, feed and water animals Check environmental conditions, such as temperature, humidity and water quality Monitor the condition of animals and making health observations Undertake domestic duties such as general cleaning and disinfection of equipment Maintain accurate written and computer-based records Perform culling and basic organ dissections Carry out a range of husbandry tasks to support researchers For a full list of duties please see the job description here. About you You will bring A minimum of 5 GCSEs or equivalent including Maths and/or Science Evidence of effectively contributing to a team Good time management and organisational skills Good observational and attention to detail skills Clear and effective written and oral communication skills Proven accurate record keeping skills Computer literacy You will demonstrate A desire to work in the laboratory animal technology field Empathy towards the care and use of animals in science The ability to meet the demands of a physically demanding role A willingness to participate in regular essential animal care overtime To see more about role/team click here. Minimum criteria About Working at the Crick Our values Everyone who works at the Crick has a valuable role to play in advancing the Crick s mission and shaping our culture! We are bold. We make space for creative, dynamic and imaginative ideas and approaches. We re not afraid to do things differently. We are open. We re highly collaborative and interactive, and make sure our activities are visible to the outside world. We are collegial. We show respect for one another, work cooperatively and support the wider community. At the Francis Crick Institute, we believe that diversity and inclusion are essential to driving innovation and scientific discovery. We are committed to creating a workplace where everyone feels valued, respected, and empowered to succeed, regardless of their background, identity, or personal circumstances. We actively encourage applications from individuals of all genders, ethnicities, abilities, and experiences. We are a Disability Confident: Committed employer and want to ensure that everyone can apply and be part of our recruitment processes and so we'll make reasonable adjustments if you need them - just let us know when you apply. If you need assistance with applying (i.e., would like to apply by phone or post) please contact us via our website. Find out more about life at the Crick. What will you receive? At the Francis Crick Institute, we value our team members and are proud to offer an extensive range of benefits to support their well-being and development: Generous Leave: 28 days of annual leave, plus three additional days over Christmas and bank holidays. Pension Scheme: Defined contribution pension with employer contributions of up to 16%. Health & Well-being: 24/7 GP consultation services. Occupational health services and mental health support programs. Eye care vouchers and discounted healthcare plans. Work-Life Balance: Back-up care for dependents. Childcare support allowance. Annual leave purchase options. Perks: Discounted gym memberships, bike-to-work scheme, and shopping discounts. Subsidised on-site restaurant and social spaces for team interaction. Please note you must meet the essential criteria listed within the Role Profile, to have your application reviewed. We reserve the right to withdraw this advert at any given time due to the number of applications received.
BRF Animal Technician Details of the role: Full time, permanent 36 hours Part-time opportunities may also be available, please note any preferred working pattern in your application. About us The Francis Crick Institute is Europe s largest biomedical research institute under one roof. Our world-class scientists and staff collaborate on vital research to help prevent, diagnose and treat illnesses such as cancer, heart disease, infectious diseases and neurodegenerative conditions. The Biological Research Facility is the Crick s animal facility offering services to those researchers who use animals such as mice and fish to answer their research questions. For example, studying the effects of genes on development, or identifying the molecules involved in how cancer spreads. The Biological Research Facility supports all animal research at the Crick through its comprehensive animal care and use programme, and provides the Crick's laboratory animal resource and technical services. There are approximately 150 animal care staff spread across several self-contained animal units. High quality multidisciplinary experimental outcomes are at the heart of the BRF's philosophy and operations, delivered to the highest of animal welfare standards. The BRF teams integrate husbandry of multiple species within a range of facilities, using state of the art technologies, via a talented and skilled team. About the role This role is ideal for anyone who s passionate about working with animals, dedicated to animal welfare, and enjoys hands-on, practical work. If you re excited by the idea of creating the best possible environment for animals in a research setting, while directly contributing to world-leading scientific discoveries, the Francis Crick Institute could be the perfect place to build a meaningful career in Animal Technology. We re looking for enthusiastic, self-motivated team players to join us as Animal Technicians, key members of our organisation who play a vital role in enhancing the quality of life for our laboratory animals. You ll work within our state-of-the-art animal facility, carrying out husbandry duties and supporting the full breadth of research at the Crick through our comprehensive animal care and use programme. At the Francis Crick Institute, we re committed to helping you grow. We provide thorough training and ongoing support so you can build a rewarding career where your work makes a real difference to both research and animal welfare. Whether you re seeking a new challenge or taking the next step in your career, this could be the opportunity you ve been looking for. As a new technician, you ll learn all aspects of animal husbandry, gain experience using our record-keeping systems, and develop a solid understanding of the legal frameworks that guide our work. You ll also complete the IAT Level 2 qualification and have the chance to obtain a Home Office Personal Licence. Our BRF Research Officer roles open the door to long-term growth, continuous learning, and clear career progression, making this a fantastic pathway for anyone looking to develop their skills and build a future in Animal Technology. What you will be doing As an Animal Technician at the Crick, you will: Provide excellent care, welfare and husbandry to laboratory animals Clean, feed and water animals Check environmental conditions, such as temperature, humidity and water quality Monitor the condition of animals and making health observations Undertake domestic duties such as general cleaning and disinfection of equipment Maintain accurate written and computer-based records Perform culling and basic organ dissections Carry out a range of husbandry tasks to support researchers For a full list of duties please see the job description here. About you You will bring A minimum of 5 GCSEs or equivalent including Maths and/or Science Evidence of effectively contributing to a team Good time management and organisational skills Good observational and attention to detail skills Clear and effective written and oral communication skills Proven accurate record keeping skills Computer literacy You will demonstrate A desire to work in the laboratory animal technology field Empathy towards the care and use of animals in science The ability to meet the demands of a physically demanding role A willingness to participate in regular essential animal care overtime To see more about role/team click here. Minimum criteria About Working at the Crick Our values Everyone who works at the Crick has a valuable role to play in advancing the Crick s mission and shaping our culture! We are bold. We make space for creative, dynamic and imaginative ideas and approaches. We re not afraid to do things differently. We are open. We re highly collaborative and interactive, and make sure our activities are visible to the outside world. We are collegial. We show respect for one another, work cooperatively and support the wider community. At the Francis Crick Institute, we believe that diversity and inclusion are essential to driving innovation and scientific discovery. We are committed to creating a workplace where everyone feels valued, respected, and empowered to succeed, regardless of their background, identity, or personal circumstances. We actively encourage applications from individuals of all genders, ethnicities, abilities, and experiences. We are a Disability Confident: Committed employer and want to ensure that everyone can apply and be part of our recruitment processes and so we'll make reasonable adjustments if you need them - just let us know when you apply. If you need assistance with applying (i.e., would like to apply by phone or post) please contact us via our website. Find out more about life at the Crick. What will you receive? At the Francis Crick Institute, we value our team members and are proud to offer an extensive range of benefits to support their well-being and development: Generous Leave: 28 days of annual leave, plus three additional days over Christmas and bank holidays. Pension Scheme: Defined contribution pension with employer contributions of up to 16%. Health & Well-being: 24/7 GP consultation services. Occupational health services and mental health support programs. Eye care vouchers and discounted healthcare plans. Work-Life Balance: Back-up care for dependents. Childcare support allowance. Annual leave purchase options. Perks: Discounted gym memberships, bike-to-work scheme, and shopping discounts. Subsidised on-site restaurant and social spaces for team interaction. Please note you must meet the essential criteria listed within the Role Profile, to have your application reviewed. We reserve the right to withdraw this advert at any given time due to the number of applications received.
