Regulatory Affairs Associate

Regulatory Affairs Associate

Office-based (with some flexibility)
Occasional national & international travel
Salary: £42,000 -£44,000
Location; Gloucester

We are looking for a detail-driven and motivated 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. Occasional national and international travel may be required.

Closing date is 27th June 2026

Hawk 3 Talent Solutions are operating as an employment agency on behalf of its client.

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Hawk 3 Talent Solutions are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future