Compliance Manager, Healthcare

Compliance Manager required for our client based in Stevenage, they are a rapidly growing UK-based health tech start-up that’s building wearable technology with the power 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, as well as other markets and leading external audits and test houses.

This role sits at the interface of engineering, operations, suppliers, and (where needed) regulatory consultants/notified bodies. 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.

• 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)