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IVDR Regulatory Specialist II: EU Submissions & Strategy

Planet Pharma, South Portland, ME, United States


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. #J-18808-Ljbffr