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Regulatory Affairs Manager

Regulatory Affairs Manager

Skills AllianceDanbury, CT, United States
21 hours ago
Job type
  • Full-time
Job description

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

  • 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.
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    Regulatory Manager • Danbury, CT, United States