Regulatory Affairs Coordinator

2 weeks ago


Chicago, Illinois, United States PSG Global Solutions Full time

We are seeking a Regulatory Affairs Associate to join our team at PSG Global Solutions, specializing in the Biotechnology and Medical Devices sectors.


Position Overview:

In this role, you will be responsible for managing the submission of essential applications and overseeing all interactions with regulatory bodies related to the approval process for products that require governmental consent.


Key Responsibilities:
  • Authoring and submitting various regulatory documents, including PMA supplements, 30-day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
  • Reviewing and approving engineering study protocols and reports, as well as validation study protocols and reports.
  • Evaluating and approving modifications in manufacturing processes for Class III implantable medical devices.

This position is crucial for ensuring compliance with regulatory standards and facilitating the smooth approval of innovative medical products.



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