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Senior Regulatory Affairs & Quality Manager

Last week

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

Complaints Data Analyst (Post Market)

3 weeks ago

Carbon 60 London £50 – £65 ph

Analyses post-market complaints and quality data for a global medical device portfolio, leading monthly product quality monitoring and statistical trending to surface emerging risks. Builds and maintains Power BI dashboards and reporting tools, conducts complaint investigations and ad hoc reviews, and supports EU MDR trending, audits and CAPA activities alongside Quality, Regulatory, Clinical, R&D and Operations teams.

Remote Temporary

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