Regulatory Specialist II - IVDR (EU) Onsite
abbottSouth Portland (ME)
Regulatory Specialist II - IVDR (EU) Onsite
Posted today
abbottSouth Portland (ME)
SENIORITY
Senior
About the role
Abbott in South Portland, ME seeks a Regulatory Specialist II to manage IVDR-compliant technical writing and regulatory support for diagnostic products. The role develops regulatory strategies for EU and international approvals, supports regional teams with submissions and license amendments, and maintains ongoing marketing authorizations. Responsibilities include preparing submission documents, organizing files, and training stakeholders while ensuring compliance with ISO, FDA, and other
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