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
* Sounds 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 01453 829523 or ben.herd@omegaresource.co.uk
Omega Resource Group is acting as an Employment Agency in relation to this vacancy.
Omega Resource Group is an employment agency specialising in opportunities at all levels within the Engineering, Aerospace, Automotive, Electronics, Defence, Scientific, Oil & Gas, Construction and Manufacturing sectors.
For details of other opportunities available within your chosen field please visit our website www.omegaresource.co.uk