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Medical Science Liaison Healthcare Compliance

IVDR Regulatory Specialist II: EU Submissions & Strategy

Job in South Portland, Cumberland County, Maine, 04106, USA
Listing for: Planet Pharma
Full Time position
Listed on 2026-02-07
Job specializations:
  • Healthcare
    Medical Science Liaison, Healthcare Compliance
Job Description & How to Apply Below
A leading pharmaceutical company is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product registrations. Applicants should possess a Bachelor's degree in a related technical field and have over 4 years of experience in Regulatory Affairs, particularly with IVDR and EU regulations. Key responsibilities include providing regulatory support for product development, compiling submission documents, and maintaining approvals for marketing authorizations.

This role emphasizes strong communication and time management skills.
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