RA Associate

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...