Bluetree · 11–50 people
Senior Regulatory Affairs & Quality Manager
- Cambridge
- Hybrid · 2 days in office
- £65,000 – £80,000 pa
- Senior
- Permanent
Lead regulatory strategy for a cardiology device company expanding into the US, UK, EU and Middle East, owning FDA, CE and UKCA submissions from Class I to Class II/III. Drive an audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971) and advise senior leadership on regulation, quality and clinical governance, working directly with the FDA, MHRA and notified bodies.
FDA · MHRA · UKCA +2
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