Regulatory Affairs Associate

Regulatory Affairs Associate

Office-based (with some flexibility). Occasional national & international travel. Salary: £42,000 – £44,000. Location: Gloucester.

We are looking for a detail‑driven and motivated Regulatory Affairs Associate to join a growing and dynamic team within the medical devices sector. This role is a key part of ensuring regulatory compliance across international markets, supporting the development of life‑changing products while working in a highly collaborative, quality‑focused environment.

What You’ll Do

• Support MDR technical documentation (Annex II & III)
• Contribute to UK & international registrations (MHRA, EU, FDA)
• Maintain ISO 13485 compliant documentation
• Assist with PMS, vigilance, and audits
• Collaborate across Engineering, Quality & Manufacturing
• Review labelling and compliance for global markets

What You’ll Bring

• 2+ years in medical device regulatory or quality roles
• Strong knowledge of MDR, MDD & ISO 13485
• Excellent attention to detail & technical writing
• A proactive, organised and team‑focused mindset

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