Regulatory Affairs Associate - Remote

Intellectt Inc Remote
regulatory remote supplements class iii remote protocols medical medical devices devices asap regulatory pm government
March 16, 2023
Intellectt Inc
Garland, Texas
Hi,

Greetings of the day

This is Gowri Sankar from Intellectt INC. Please check out the following requirement and let me know your interest ASAP

Role: Regulatory Affairs Associate

Location: Abbott Park, IL 60064 (Remote)

Shift Timings: 8 AM to 5 PM

Remote with 1 day at office (Plymouth, MN or Maple Grove, MN)

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, and 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.
  • May require an advanced degree and 5-8 years of direct experience in the field.
  • 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.
Education & Experience Required
  • Bachelor's required.
  • 3 to 5 years Addressing Regulators abroad, direct submissions Internationally / Device exp preferred, will consider Pharma.

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