Regulatory Affairs Associate

Regulatory Affairs Associate

Omega Gloucester, England, United Kingdom

Our client, a global leading manufacturing business based in Gloucester, is hunting for a detailed and organised Regulatory Affairs Associate.

In this role, your key responsibility is to maintain regulatory compliance, obligations to international regulations and organisation of related technical documentation.

Other responsibilities include:

• Ensure documentation aligns with ISO 13485, ISO 14971 and where applicable IEC 62366-1
• Support preparation, review, and maintenance of Technical Documentation, including device description, GSPR, risk management, clinical evaluation, PMS, PMCF, and labelling.
• Partner with R&I, Engineering, Quality, Manufacturing, Sales and Supply Chain to ensure regulatory deliverables are embedded and on time
• Support international registrations (e.g., FDA listing support, Canada, Australia) as business needs evolve.

• Proven experience in a medical device regulatory/quality role
• Strong understanding of regulatory processes within med devices standards (ISO 13485, MDR, FDA 21 CFR Part 280)
• Internal QMS auditing experience
• Ability to prioritise and deliver to deadlines in a regulated environment.

Candidates who currently are a Regulatory Affairs Associate, Regulatory Affairs Engineer, Regulatory Affairs Specialist or Quality & Regulatory Associate may be suitable for this position.

For more information regarding this Regulatory Affairs Associate role please contact Ben Herd on or

Omega Resource Group is acting as an Employment Agency in relation to this vacancy.

• Mid‑Senior level

• Full‑time

• Quality Assurance and Manufacturing

• Engineering Services
• Medical Equipment Manufacturing
• Machinery Manufacturing

Referrals increase your chances of interviewing at Omega by 2x.