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Regulatory Affairs Specialist – IVDR EU Diagnostics
Job in
South Portland, Cumberland County, Maine, 04106, USA
Listed on 2026-02-07
Listing for:
GForce Life Sciences
Full Time
position Listed on 2026-02-07
Job specializations:
-
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
A life sciences company in South Portland, Maine is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product registrations. The ideal candidate will have at least 4 years' experience in Regulatory Affairs and a strong understanding of IVDR and EU regulations. Key responsibilities include developing regulatory strategies for product clearance and providing support for commercial diagnostic products.
The role demands excellent communication skills and proficiency in Microsoft Office.
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