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Raqa manager: iso 13485 & fda strategy lead

Loughborough
Cure Talent
Manager
€60,000 a year
Posted: 21h ago
Offer description

A wearable medical technology company in Loughborough seeks a RAQA Manager to establish and lead the Quality and Regulatory function. The role involves implementing ISO 13485 certification and defining US regulatory strategy, including 510k submissions. This high-impact position is key to enabling commercialisation and requires a professional with experience in regulatory affairs, quality systems, and an understanding of both US and European regulatory pathways. Ideal candidates will exhibit strong leadership and technical skills to manage compliance effectively.
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