Regulatory Affairs Manager

Regulatory Manager – Point-of-Care Diagnostics

Connecticut (Hybrid) Full-time

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

Why This Role