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