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.