Minnnesota Bioscience Jobs

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System One Services Regulatory Affairs Associate in St Paul, Minnesota

Regulatory Affairs AssociateSt Paul, Minnesota

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Type:Contract

Category:Scientific & Clinical

Job ID:186264

Date Posted:02/11/2021

Job Title: Regulatory Affairs Associate

Contract Length: 9 mos

Number of Openings: 1

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.

  • 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.

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