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

Our client, a global leading manufacturing business based in Gloucester are on the hunt for a detailed and organised Regulatory Affairs Associate!

Role and Responsibilities – 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.

Experience or Qualifications – Regulatory Affairs Associate

Proven experience in a medical device regulatory / quality role ...