Office-based (with some flexibility)
Occasional national & international travel
Salary: £42,000 - £44,000
Location: Gloucester
Regulatory Affairs Associate to join a growing and dynamic team within the medical devices sector.
This is a fantastic opportunity to play a key role in ensuring regulatory compliance across international markets, supporting the development of life‑changing products while working in a highly collaborative, quality‑focused environment.
The Role
Reporting into the Regulatory Affairs function, you will play a key role in maintaining compliance with international medical device regulations and supporting the creation and maintenance of technical documentation.
Key Responsibilities
* Support the preparation and maintenance of MDR Technical Documentation (Annex II & III)
* Assist with Class IIa conformity assessments and Notified Body interactions
* Support UK and international regulatory registrations including MHRA, FDA, Canada, and Australia
* Maintain regulatory documentation in line with ISO 13485 and ISO 14971 requirements
* Support post‑market surveillance, vigilance, and PMCF activities
* Review labelling, IFUs, and promotional materials for regulatory compliance
* Work cross‑functionally with Quality, Engineering, Manufacturing, and Commercial teams
* Support internal, customer, and external audits
* Assist with UDI management, EUDAMED registrations, and regulatory change activities
About You
* Minimum 2 years’ experience within Regulatory Affairs or Quality in the medical device industry
* Good understanding of MDR, MDD, ISO 13485, and FDA 21 CFR Part 820
* Experience supporting technical documentation and regulatory submissions
* Strong technical writing and document control skills
* Excellent attention to detail and analytical capability
* Confident working across multiple stakeholders and departments
* Internal auditing experience would be advantageous
* Experience with Class IIa medical devices and eQMS systems is desirable
What’s On Offer
* Opportunity to join a growing medical device organisation
* Collaborative and supportive culture
* Exposure to international regulatory activities
* Career development opportunities within Regulatory Affairs
This role is primarily office‑based with some flexibility for remote working.
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