Regulatory Affairs Manager
Skills AllianceDanbury, CT, US17 hours ago
Job type
- Full-time
- Part-time
Job description58+ 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. 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.
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
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Regulatory Manager • Danbury, CT, US
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