Medical Device jobs in United Kingdom
Field Service Engineer - Medical Devices (Company Car)
Alcon
ENT Territory Sales Leader – Northern UK
PowerToFly
ENT Territory Sales Manager – Northern UK (Field-Based)
Stryker Group
Discover more opportunities than anywhere else. Find more jobs nowQuality Systems Specialist - Document Control
Stryker Group
Connect with headhunters to apply for similar jobsENT Territory Sales Leader Northern UK (Hybrid)
Stryker UK Limited
Medical Devices Territory Sales Lead - London & Kent
Gi Group
ENT Territory Sales Leader Northern UK (Hybrid)
Stryker UK Limited
Strategic Account Manager, Coronary Therapies (Remote)
Boston Scientific
EU Critical Care Territory Manager (GlideScope)
Verathon
Territory Manager - Critical Care (UK - SW)
Verathon
Regulatory Affairs Associate
Job summary
A global manufacturing business based in Gloucester seeks a Regulatory Affairs Associate to ensure compliance with international regulations. The successful candidate will manage associated technical documentation and collaborate across departments. The role requires proven experience in medical device regulatory functions and knowledge of relevant standards. Candidates should be detail-oriented and organized to thrive in a regulated environment.
Qualifications
- Proven experience in a medical device regulatory / quality role.
- Sound understanding of regulatory processes within medical device standards.
- Internal QMS auditing experience.
Responsibilities
- Ensure documentation aligns with ISO 13485, ISO 14971 and applicable IEC.
- Support preparation, review, and maintenance of technical documentation.
- Partner with various departments to ensure regulatory deliverables.
Skills
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.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.