Regulatory Affairs Specialist

Regulatory Affairs Coordinator

Hertford

Hybrid/Part-Time Working Available

Up to £40,000

An established manufacturer of regulated products is seeking a Regulatory Affairs Coordinator to support the ongoing maintenance of compliance and technical documentation across an established portfolio of products.

This is a hands-on role suited to someone who enjoys practical regulatory work within an SME environment and can efficiently manage documentation and compliance activities without unnecessary complexity.

Responsibilities:

Maintain UK and EU product registrations.
Review and maintain Technical Files and supporting documentation.
Prepare and maintain PMS, PSUR and Clinical Evaluation documentation.
Review and update IFUs and product labelling.
Monitor regulatory updates and ensure ongoing compliance.
Prepare technical justifications, gap analyses and briefing notes.
Support customer regulatory queries and external audits.
Maintain electronic and physical document control systems.

Requirements:

Previous experience within medical devices, regulatory affairs or quality assurance.
Knowledge of ISO13485 and medical device regulations including MDR, MDD and UKCA.
Experience with Technical Files and technical documentation.
Strong organisational skills and attention to detail.
Comfortable working independently within an SME environment.Unfortunately, sponsorship is not available for this position, so applicants must already hold full and unrestricted right to work in the UK