Director of Regulatory Affairs
9 hours ago
1 week ago Be among the first 25 applicantsDirect message the job poster from Hartmann YoungHeadhunter | Specialising in Diagnostics & Genomics | Connecting Top Talent across the Industry Associate Director – Regulatory Affairs (IVD) | CambridgeHartmann Young is partnered with an innovative and fast-growing diagnostics company based in Cambridge. We’re seeking a proactive and experienced Associate Director of Regulatory Affairs to lead global regulatory strategy across a portfolio of pioneering IVD technologies. This is a high-impact, hands-on leadership role supporting both FDA and IVDR pathways, ideal for someone who thrives in a collaborative, cross-functional environment.You’ll work closely with R&D, Clinical, Quality, and Operations teams to bring impactful diagnostic solutions to global markets — from early development through to registration and post-market compliance.Key Requirements:Proven experience in regulatory affairs within the IVD, diagnostics, or medical device sectorsDemonstrated success with FDA submissions (e.g., 510(k), Pre-Subs)Strong working knowledge of EU IVDR and technical documentation requirementsSkilled at interpreting complex regulatory requirements and translating them into actionable strategiesConfident liaison with regulatory authorities and notified bodiesCollaborative mindset, comfortable working across functions and influencing senior stakeholdersAble to manage multiple regulatory projects and priorities in a fast-paced settingDetail-oriented, analytical, and highly organisedLeadership of regulatory strategy from development through post-marketExperience working in small-to-mid-sized or scaling life sciences companiesFamiliarity with companion diagnostics, point-of-care, or molecular platformsLocation: Cambridge (Hybrid – 3 days/week in-office) - REQUIREDPlease apply directly or reach out to jamie.cross@hartmannyoung.com for more information.Seniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionOtherReferrals increase your chances of interviewing at Hartmann Young by 2xGet notified about new Director of Regulatory Affairs jobs in Cambridge, England, United Kingdom.Cambridge, England, United Kingdom 1 month agoContracts - Experienced Regulatory Affairs Professionals - Manager to Director LCambridge, England, United Kingdom 20 hours agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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Regulatory Affairs Director
7 days ago
Cambridge, United Kingdom AstraZeneca Full timeJoin to apply for the Regulatory Affairs Director role at AstraZeneca. Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life‑changing medicines? At AstraZeneca, we do this with the utmost integrity, forging partnerships that help bring world‑class...
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Senior Regulatory Affairs Director
2 weeks ago
Cambridge, United Kingdom AstraZeneca Full timeAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
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Regulatory Affairs Director
7 days ago
Cambridge, United Kingdom AstraZeneca Full timeWould you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicinesAt AstraZeneca we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships...
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Senior Regulatory Affairs Director
1 week ago
Cambridge, United Kingdom AstraZeneca Full time £125 - £150At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
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Senior Regulatory Affairs Director
2 days ago
Cambridge, Cambridgeshire, United Kingdom AstraZeneca Full timeAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
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Regulatory Affairs Manager
4 days ago
Cambridge, United Kingdom Walker Cole International Full timeA 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 from early development through...
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Senior Manager Regulatory Affairs
2 weeks ago
Cambridge, United Kingdom Quanta part of QCS Staffing Full timeSenior Manager Regulatory Affairs - Pharmaceuticals - Cambridge Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Manager Regulatory Affairs. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join...
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Regulatory Affairs Manager
1 week ago
Cambridge, United Kingdom Russell Taylor Group Ltd Full timeRegulatory Affairs Manager Location: CambridgeshireEmployment 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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Regulatory Affairs Manager
5 days ago
Cambridge, United Kingdom Russell Taylor Group Ltd Full timeRegulatory Affairs ManagerAll the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.Location: CambridgeshireEmployment 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...
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Regulatory Affairs Manager
1 week ago
Cambridge, United Kingdom Russell Taylor Group Ltd Full timeRegulatory Affairs ManagerAll the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.Location: CambridgeshireEmployment 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...
