Job Description

Regulatory Manager Point-of-Care Diagnostics

📍 Connecticut (Hybrid) | Full-time

Im partnered with a fast-growing medical diagnostics startup developing point-of-care technology that provides rapid insight into a patients coagulation status. Their platform is already progressing in the EU and gaining strong clinical traction.

Theyre 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

• 58+ 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.

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