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Job Title


Regulatory Affairs Manager


Company : CAPU Search


Location : swindon, wiltshire


Created : 2025-06-20


Job Type : Full Time


Job Description

Were Hiring: Team Leader Regulatory Affairs (IVD) Edinburgh area | Remote with occasional site visit A growing diagnostics innovator is building out its UK-based Regulatory Affairs team and looking for a Team Leader to help drive forward their global compliance efforts.With ~80 IVD products already on the market across the US, Canada, Europe, Australia, and more, the business is shifting from a split international model to a fully integrated RA function covering pre-market, post-market, and continuous improvement activities from one central team. About the RoleYoull lead a small team (including RA officers and admin staff), take ownership of regulatory input into product changes and compliance activities, and play a key role in embedding structure and clarity into the teams day-to-day operations. Theres genuine scope for progression as the business grows. Key ResponsibilitiesCoordinate and oversee regulatory input for product changes and ongoing compliance workMentor and support junior team membersLiaise with manufacturing, QA, and project leads to ensure smooth project deliverySupport submission planning and document updates for international registrations What Were Looking ForStrong working knowledge of IVD regulations (IVDD/IVDR essential)Exposure to global markets (FDA, Health Canada, etc. preferred)Proactive communicator with practical, solutions-oriented thinkingBased within commuting distance or able to commit to regular time on-site Salary: 6065k (depending on experience) Permanent, full-time Remote flexibility