Regulatory Affairs Associate

Position: Regulatory Affairs Associate
Location: Gloucester
Job Type: Permanent / Onsite (Hybrid)

Our client, a global leading manufacturing business based in Gloucester, is seeking a detailed and organised Regulatory Affairs Associate to maintain regulatory compliance, obligations to international regulations and the organization of related technical documentation.

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

• Ensure documentation aligns with ISO 13485, ISO 14971 and where applicable IEC.
• 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.
• Sound understanding of regulatory processes within medical device standards (ISO 13485, MDR, FDA 21 CFR Part 280).
• Internal QMS auditing experience.
• Ability to prioritize 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.