EU Regulatory Lead — Medical Devices & POC Diagnostics

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

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.