Regulatory Affairs Associate

Our client, a global leading manufacturing business based in Gloucester are on the hunt 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
• Good understanding of regulatory processes within medical device 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