Compliance Manager, Healthcare

Overview

Position: Compliance Manager

Location: Stevenage

Salary: £50,000-£60,000 (dependent on experience)

Compliance Manager required for our client based in Stevenage, a rapidly growing UK-based health tech start-up building wearable technology to support people living with neurological conditions.

They are looking for a Compliance Manager to own our compliance roadmap end-to-end: building and maintaining a compliant QMS (ISO 13485-aligned), managing certification / technical documentation for UKCA / CE (UK / EU), coordinating FCC for the US market, and leading external audits and test houses.

This role sits at the interface of engineering, operations, suppliers, and regulatory consultants / notified bodies (where needed). You will ensure our documentation, processes, and evidence are audit-ready and proportionate to the company's stage.

• Own our regulatory plan for UKCA (UK), CE marking (EU), and FCC (US), aligned to product claims, intended use, risk classification, and target markets.
• Maintain a compliance matrix covering applicable standards and regulations (e.g., EMC, electrical safety, biocompatibility if relevant, labelling / IFU, UDI where applicable).
• Coordinate with external test labs, regulatory consultants, and (if applicable) Notified Bodies / UK Approved Bodies.
• Ensure product marketing claims remain consistent with regulatory positioning and evidence.
• Design, implement, and maintain a Quality Management System suitable for a medical device manufacturer (typically ISO 13485; with ISO 9001 where useful).
• Own and maintain the product Technical File / Technical Documentation, ensuring it is complete, current, and defensible.
• Ensure traceability from requirements → risk controls → verification / validation → release.

• Experience leading ISO 13485 (or equivalent medical-device QMS) implementation and / or maintenance, including external audits.
• Strong working knowledge of UKCA / CE regulatory pathways for medical devices and associated technical documentation expectations.
• Experience coordinating EMC / radio / safety testing and managing third-party test houses.
• Practical experience with CAPA, document control, change control, supplier quality, and complaint handling.

• Salary - £50,000-£60,000 (dependent on experience)
• Monday to Friday (09:00 to 17:00)
• On-site position
• Holiday package
• Pension scheme