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Regulatory Affairs Associate

4 months ago

Lake Forest, United States PSG Global Solutions Full time

Description We're looking for a

Regulatory Affairs Associate , working in

Biotechnology/Medical Devices

industry in

100 Abbott Park Road, Lake Forest, Illinois, 60064, United States .

Job description:

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices.

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