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 with deep, practical expertise in the FDA and EU/UK MDR, who can interpret complex regulation with confidence and is comfortable working at a detailed level. 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 submissions for Class II devices, including 510(k) and De Novo, alongside CE and UKCA submissions for Class IIa/IIb devices
• Driving a compliant, audit-ready QMS (ISO 13485, FDA QMSR, 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
• Exceptional, hands-on FDA expertise, with a track record of successful 510(k) and/or De Novo submissions and direct engagement with the FDA, including Pre-Submission (Q-Sub) meetings and inspections
• Exceptional, hands-on CE and UKCA marking expertise under EU MDR and UK MDR, including technical documentation and notified body audits
• 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.