Consultant | Medical Devices | QARA United States & Europe
Regulatory Manager – Point-of-Care Diagnostics
I’m partnered with a fast-growing medical diagnostics startup developing point-of-care technology that provides rapid insight into a patient’s coagulation status. Their platform is already progressing in the EU and gaining strong clinical traction.
They’re now looking for a hands‑on Regulatory Manager to drive EU regulatory strategy and submissions as they scale.
The Role
- Lead and support regulatory activities with strong focus on EU CE/IVDR submissions .
- Prepare, coordinate, and maintain technical documentation for CE/IVDR.
- Integrate regulatory requirements across the product lifecycle (hardware, consumables & software).
- Act as point of contact with Notified Bodies; support audits, Q&A, and remediation.
- Partner with Quality, Engineering, and R&D on documentation, risk management, and compliance.
The Profile
- 5–8+ years’ Regulatory Affairs experience in medical devices or diagnostics.
- Proven experience working on CE/IVDR submissions .
- Strong familiarity with ISO 13485, ISO 14971, IEC 62304, and EU regulatory frameworks .
- Comfortable in a startup environment, hands‑on, adaptable, and collaborative.
Why This Role
- Shape regulatory strategy in a scaling, high‑impact environment.
- Work on technology with meaningful clinical application in emergency and critical care.
- Highly cross‑functional role with broad ownership and visibility.