Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Escape Recruitment ServicesEngineering and Manufacturing Recruitment Specialist | Matching Skills with Opportunities | Relationship Building | Driving Growth Through TalentRegulatory Affairs Department Lead (PRRC)Location: Central Scotland with hybrid or remote working availableWe are recruiting for an experienced Regulatory Affairs Department Lead to join our client, a well-established and respected name in the medical device and in vitro diagnostics (IVD) industry. This is a senior leadership role where you'll oversee a small, capable team and take responsibility for regulatory compliance across multiple global markets, including the US, Canada, and Europe.The focus is on someone who can bring real depth of experience with high-risk Class D devices, and who understands the complexities of IVDR, FDA and Health Canada regulations inside out. You'll need to be comfortable leading from the front, acting as PRRC, and steering technical documentation, submissions, and post-market activities through a constantly evolving regulatory landscape.What you'll be doing:Lead and develop the Regulatory Affairs department, managing a small teamOversee preparation, review and maintenance of technical documentation and submissions for Class D IVD devices (IVDR, FDA 510(k)/PMA, Health Canada)Act as Person Responsible for Regulatory Compliance (PRRC) and ensure compliance with GMP and ISO13485Support post-market surveillance, vigilance and risk management processesAct as a key point of contact with regulatory bodies and external partnersWork closely with other departments to align regulatory work with wider business prioritiesMaintain a regular on-site presence, with flexibility around hybrid or remote workingWhat you'll need:Extensive regulatory affairs experience within IVD or medical devicesProven track record with regulatory submissions for high-risk Class D devicesStrong knowledge of IVDR, FDA and Canadian medical device regulationsHands-on experience of post-market compliance, risk and vigilance activitiesPeople management experience, with the ability to lead and mentor a teamA collaborative approach and the confidence to work with internal stakeholders and regulatory bodiesFluent English and excellent communication skillsMust already have the right to work in the UKWhat next?If you're looking for a senior role where you can make a real impact and bring your expertise to a high-performing team, we'd love to hear from you. Send your CV or contact us to find out more.Seniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionLegal and Quality AssuranceIndustriesMedical Equipment Manufacturing and Pharmaceutical ManufacturingReferrals increase your chances of interviewing at Escape Recruitment Services by 2xSign in to set job alerts for “Regulatory Affairs Manager” roles.Manager - Regulatory Controls, CIB Chief Control OfficeEdinburgh, Scotland, United Kingdom 6 days agoEdinburgh, Scotland, United Kingdom 1 day agoPenicuik, Scotland, United Kingdom 2 weeks agoManager - WAM Risk and Regulatory AdvisoryEdinburgh, Scotland, United Kingdom 2 weeks agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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