Minnnesota Bioscience Jobs

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System One Services Regulatory Affairs Associate in St. Paul, Minnesota

Regulatory Affairs AssociateSt. Paul, Minnesota (/all-jobs?geoId=40598171-75ef-11e6-9d1e-bc764e10a8d2)

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Type:Contract

Category:Scientific & Clinical

Job ID:183083

Date Posted:12/04/2020

Job Information:

Job Title:Regulatory Affairs Associate

Contract Length: 1 yr

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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