Regulatory Affairs Manager

Skills Alliance; Danbury (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical diagnostics company in Danbury, Connecticut is seeking a hands-on Regulatory Manager to drive EU regulatory strategy and submissions for their point-of-care technology. The ideal candidate will have 5–8+ years of Regulatory Affairs experience in medical devices, proven experience with CE/IVDR submissions, and familiarity with relevant ISO standards. This role offers the opportunity to shape regulatory strategy in a high-impact, cross-functional environment.

Qualifications

• 5–8+ years’ experience in Regulatory Affairs in medical devices or diagnostics.
• Proven experience with CE/IVDR submissions.
• Strong familiarity with relevant ISO standards and EU regulatory frameworks.

Responsibilities

• Lead and support regulatory activities for EU CE/IVDR submissions.
• Prepare and maintain technical documentation.
• Partner with cross-functional teams to ensure compliance.

Skills

Regulatory Affairs experience

CE/IVDR submissions

ISO 13485

ISO 14971

IEC 62304

Comfortable in startup environment

Job description

Consultant | Medical Devices | QARA United States & Europe

Regulatory Manager – Point-of-Care Diagnostics

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.