Regulatory Affairs Associate

Company: PSG Global Solutions
Location: Lake Forest
Posted on: January 16, 2023

Job Description:

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.

Keywords: PSG Global Solutions, Lake Forest , Regulatory Affairs Associate, Other , Lake Forest, California

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