Regulatory Compliance Manager (Medical Device / Wearables)
Location: Stevenage, UK (Office-based) 4 days on site per week
Type: Full-time
The Opportunity:
Our Client are a growing scale up health-tech company who have developed a life changing wrist‑worn wearable device that delivers precisely controlled haptic stimulation. As they scale, we are seeking a hands‑on ISO & Regulatory Compliance Manager to own their compliance roadmap end‑to‑end.
This is a pivotal role where you will build and maintain a Regulatory and Compliance function for the business, including building a robust Quality Management System (QMS) and managing 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.
Essential 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.
* Strong QMS Management Experience
* Healthcare/Medical Sector Experience. Wearables would be highly preferable.
Why Join them?
You will have direct influence on product safety and market access strategy, with the opportunity to grow the compliance function as the company scales. They offer an exciting life changing product, and a culture that is evidence‑driven, pragmatic, and focused on delivering meaningful technology.
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