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Ra associate

Wick (Highland)
Permanent
GxPeople Global
Posted: 21 September
Offer description

Job Title: Regulatory Associate – Medical Devices Location: West London/ Berkshire (Hybrid or On-site, depending on candidate location) Employment Type: Full-Time Are you looking to advance your career in Regulatory Affairs within a fast-paced and impactful medical device environment? We’re hiring a Regulatory Associate to join a highly collaborative RA/QA team and play a central role in global product compliance and regulatory strategy execution. This is an exciting opportunity for someone with strong knowledge of the Medical Device Directive (93/42/EEC), EU MDR (2017/745), and ISO 13485, who thrives on autonomy, ownership, and making a real contribution to patient safety and product success. Key Responsibilities * Prepare and maintain global regulatory submissions and renewal * Support external distributors, authorized reps, and internal teams on regulatory matters * Compile and maintain MDR-compliant Technical Files and related documentation * Lead the transition of existing MDD Technical Files to MDR format * Manage post-market surveillance activities and clinical evaluation maintenance * Conduct and support complaint trend analysis and ensure accurate reporting * Monitor changes in global regulatory frameworks and advise management accordingly * Participate in external audits (e.g. Notified Body) and host internal audit...

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