Regulatory Affairs Manager Job at Skills Alliance, Danbury, CT

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  • Skills Alliance
  • Danbury, CT

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.

Job Tags

Full time, Part time,

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