Regulatory Affairs Manager
4 days ago
Regulatory Affairs Manager Location: Cambridgeshire Employment Type: (Full-time: Mon-Fri) (Hybrid: 2 - 3 days on site) We are seeking an experienced Regulatory Affairs Manager to lead global regulatory activities across a product portfolio and ensure the products remain safe, effective, and compliant for worldwide markets. This is an exciting opportunity for a proactive regulatory professional to shape regulatory strategy, influence product development, and play a key leadership role within the RA department. What you'll be doing Lead regulatory strategies and submissions for new and updated products. Act as the regulatory lead and SME for product development projects, providing solution-focused guidance. Review and approve technical documentation, risk management files, performance evaluation evidence and submission materials. Manage global registrations, regulatory submissions, and interactions with authorities, authorised representatives, distributors, and external partners. Oversee post‑market surveillance, vigilance reporting, and safety officer responsibilities. Ensure regulatory compliance of product labelling, promotional materials, and commercial documentation. Maintain accurate regulatory records, documentation systems, and databases. Provide expert interpretation of global regulations and support conformity to evolving standards. Contribute to leadership, training, and development within the RA team. Act as the Person Responsible for Regulatory Compliance (PRRC) under EU IVDR. Essential Criteria Degree‑level education or equivalent in a life science or related discipline. >5 years of experience in IVD and/or medical device regulation (preferably EU‑related). Recognisable qualification in Regulatory Affairs (e.g., RAPS, TOPRA) and evidence of ongoing CPD. Strong experience working within an ISO 13485 Quality Management System. Ability to independently manage multiple projects, department initiatives, and day‑to‑day regulatory tasks. Desirable Criteria Expertise in IVD regulatory frameworks, including 21 CFR Part 820 (QSR/QMSR). Experience in post‑market surveillance, vigilance, and product recall activities. Proven experience interacting with competent authorities, global regulators, and notified bodies. Why join us? High‑impact strategic role with global regulatory responsibility Opportunity to influence product development and organisational compliance Supportive, collaborative working environment Competitive salary and benefits package Important Information We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us #J-18808-Ljbffr
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Regulatory Affairs Manager
10 hours ago
Cambridgeshire and Peterborough, United Kingdom Walker Cole International Full timeRegulatory Affairs Manager A leading medical device and IVD manufacturer based in Cambridgeshire is looking for a Regulatory Affairs Manager. This company develops and supplies innovative diagnostic solutions used worldwide. As a Regulatory Affairs Manager, you’ll play a key role in ensuring products meet global regulatory, safety, and quality standards...
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Regulatory Affairs Manager – Med Devices
7 hours ago
Cambridgeshire and Peterborough, United Kingdom Walker Cole International Full timeA leading medical device manufacturer in Cambridge is seeking a Regulatory Affairs Manager to ensure compliance with global regulatory standards. The successful candidate will lead regulatory strategy, oversee submission preparations, and manage post-market activities. With over 8 years of experience in IVD and medical device regulations, the ideal candidate...
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Global Regulatory Affairs Lead
4 days ago
Cambridgeshire and Peterborough, United Kingdom Russell Taylor Group Ltd Full timeA leading life sciences company in Cambridgeshire is seeking a Regulatory Affairs Manager to lead global regulatory activities across a product portfolio. In this pivotal role, you'll manage regulatory submissions and ensure compliance with international regulations. The ideal candidate will have over 5 years of experience in IVD or medical device...
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Cambridge, Cambridgeshire, United Kingdom Russell Taylor Group Ltd Full timeRegulatory Affairs Manager Location: Cambridgeshire Employment Type: (Full-time: Mon-Fri) (Hybrid: 2 - 3 days on site) We are seeking an experienced Regulatory Affairs Manager to lead global regulatory activities across a product portfolio and ensure the products remain safe, effective, and compliant for worldwide markets. This is an exciting opportunity for...
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Senior Regulatory Affairs Associate, Clinical
2 weeks ago
Cambridgeshire, United Kingdom Gilead Sciences Full timeGilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. For Current Gilead Employees and...
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Regulatory Affairs Associate, Clinical Trial
2 weeks ago
Cambridgeshire, United Kingdom Gilead Sciences Full timeGilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. For Current Gilead Employees and...
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Senior Manager Regulatory Affairs
2 weeks ago
Tyne And Wear, England, United Kingdom Kinetica Full time £60,000 - £100,000 per yearSenior RA Manager – NE/ Tyne & Wear– DiagnosticsAbout the Company:We are looking for a highly regulatory Manager with experience in 510K submissions, PMA and leading senior/experienced team. This is a fully site-based role with an expected 15% travel.Responsibilities:Lead and mentor an experienced Regulatory Affairs team responsible for global...
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Regulatory Affairs Officer
2 days ago
Puddington, Cheshire West and Chester, United Kingdom Nexus Life Sciences Full timeRegulatory Affairs Officer – Pharmaceuticals Salary: £40,000 – £50,000 DOE. Are you a detail-oriented Regulatory Affairs professional with a passion for ensuring pharmaceutical compliance across global markets? This is an excellent opportunity for an RA officer to join a well-established pharmaceutical manufacturer with a strong reputation for...
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QARA Manager
6 days ago
Cambridgeshire and Peterborough, United Kingdom GxPeople Global Full timePosition:Quality & Regulatory Affairs (QARA) ProfessionalOverview:An innovative MedTech start‑up is seeking an experienced Quality and Regulatory Affairs professional to lead and maintain compliance across ISO 13485, UK MDR, and EU MDR frameworks. The company is developing a novel sampling medical device to support early detection and management of...
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Tyne and Wear, United Kingdom Prospect Health Full time**Regulatory Affairs Officer - WORK FROM HOME** Are you currently working as a Regulatory Affairs officer and looking for an exciting new opportunity? In this exciting role you have the opportunity to work from home giving you great flexibility, while also gaining support from the wider team. Our client is looking for a Regulatory Affairs Officer to join...
