Job Description
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
1. Proven experience in a medical device regulatory / quality role
2. ...