Quality Assurance Regulatory Affairs Manager

Senior Regulatory Affairs & Quality Manager - Cambridge, Cambridgeshire £65,000 – £80,000 DOE + benefits Are you the person regulators, notified bodies and leadership teams turn to when the answer really matters? Bluetree are working with an innovative cardiology medical device company in Cambridge that's taking its technology into the US and onto the world stage. They need a senior regulatory and quality leader to set the direction and deliver it. This isn't a role for someone who only manages. They want an expert who knows the FDA inside out, can interpret complex regulation with confidence, and gets stuck into the detail. This is a full time permanent hybrid role. What you'll be doing

• Leading regulatory strategy for the US first, then the UK, EU and new markets including the Middle East
• Owning FDA, CE and UKCA submissions, from Class I self-certified to Class II/III devices
• Driving a compliant, audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971)
• Advising the senior team on regulation, quality, clinical governance and risk
• Working directly with the FDA, MHRA and notified bodies, including BSI
• Deciding when to bring in consultants, and making sure the business gets value from them What you'll bring
• 15+ years in Medical Device Regulatory Affairs and Quality, including time at senior level
• Strong, hands-on experience of FDA processes and submissions
• Solid CE marking experience under EU MDR and UK MDR
• Experience of international regulation across multiple markets
• Formal training and qualifications in RA/QA. Cardiology device experience would be a real bonus Why this role? You'll be the trusted regulatory voice in a growing company. You'll have real influence on how it reaches patients worldwide, with hybrid working of 2 days a week in Cambridge. We can only consider applications from candidates who are eligible to work in the UK.