Actalent · 2 days ago

Regulatory Affairs Specialist

Maple Grove, MN

Contract

Onsite

Senior Level

8+ years exp

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Responsibilities

Lead the creation of EU MDR technical files, review product development materials, and create regulatory submissions for active implantable medical devices in the Neuromodulation Business Unit.

Work as a liaison with various teams in the organization, effectively communicating and collaborating on deliverables to meet project deadlines in line with regulatory requirements.

Author, prepare, and update Technical Files in accordance with requirements.

Serve as a core-team regulatory member for new product development.

Handle regulatory authority queries on Technical files or submissions.

Maintain a continued awareness and understanding of EU and FDA regulations and guidance documents.

Prepare regulatory submissions and directly interface with International Regulatory Agencies on assigned projects.

Qualification

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Regulatory AffairsMedical DeviceNew Product Regulatory Support (PMA)EU RegulationsFDA RegulationsEffective CommunicationCollaboration