EU Regulatory Lead — Medical Devices & POC Diagnostics

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.
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