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Senior Regulatory Affairs & Quality Manager

2 weeks ago

Bluetree Cambridge £65,000 – £80,000 pa

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.

Hybrid Permanent

Medical Affairs Director - Aesthetics

Last month

Evolve Selection Hemel Hempstead

Leads the UK Medical Affairs strategy for an aesthetics organisation, developing integrated brand medical plans and feeding medical insight into a three-year business strategy. Drives evidence generation, publication planning, real-world evidence and KOL engagement while building scientific capability across Commercial and Marketing. Manages a multidisciplinary Medical Affairs team and reports to the Country Manager.

Hybrid

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