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Regulatory Affairs Associate

Company: GForce Life Sciences
Location: Bloomington
Posted on: January 13, 2022

Job Description:

Job Details:Job Title : Regulatory Affairs Associate Duration : 12+ month's contractLocation : Abbott Park IL 60064

  • 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.
  • Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.
  • May lead and direct the work of others.
  • A wide degree of creativity and latitude is expected.
  • Typically reports to a manager or head of a unit/department.'

Keywords: GForce Life Sciences, Bloomington , Regulatory Affairs Associate, Other , Bloomington, Illinois

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