Regulatory Affairs Specialist – IVDR for EU Diagnostics

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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