Job Information
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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