ISO & Regulatory Compliance Manager (Medical Device / Wearables)
Location: Stevenage, UK (Office-based)
Type: Full-time
The Opportunity:
We are a growing health-tech company developing a wrist-worn wearable device that delivers precisely controlled haptic stimulation. As we scale, we are seeking a hands-on ISO & Regulatory Compliance Manager to own our compliance roadmap end-to-end.
This is a pivotal role where you will build and maintain a robust Quality Management System (QMS) and manage technical documentation for UKCA, CE marking, and FCC compliance.
Key Responsibilities:
Regulatory Strategy: Own the compliance plan for UK, EU, and US markets; manage the compliance matrix (EMC, safety, biocompatibility, and labeling).
QMS Leadership: Design and maintain an ISO 13485-aligned QMS, including document control, risk management (ISO 14971), and CAPA processes.
Technical Documentation: Build and own the Technical File/Design History File, ensuring full traceability from requirements to validation.
Audit & Testing: Coordinate with external test labs and Notified Bodies; lead external audits and manage responses to findings.
Supplier Quality: Establish quality agreements and ensure manufacturing partners meet regulatory expectations.
Experience & Skills:
Proven Track Record: Experience leading ISO 13485 implementation and managing external certification audits.
Market Access: Strong knowledge of UKCA/CE regulatory pathways and Technical Documentation requirements.
Technical Coordination: Experience managing third-party test houses for EMC, radio/BLE, and electrical safety testing.
Pragmatic Approach: Ability to translate complex regulations into lean, workable processes for a fast-moving product team.
Communication: Highly structured and evidence-minded; able to produce clear SOPs and audit responses.
Desirable: Experience with wearables, ISO 14971 risk management, or FDA strategy.
Why Join Us?
You will have direct influence on product safety and market access strategy, with the opportunity to grow the compliance function as the company scales. We offer a culture that is evidence-driven, pragmatic, and focused on delivering meaningful technology.
Package:
Base: Up to £75,000