System One Services Regulatory Affairs Associate in St Paul, Minnesota
Regulatory Affairs AssociateSt Paul, Minnesota
Category:Scientific & Clinical
Job Title: Regulatory Affairs Associate
Contract Length: 9 mos
Number of Openings: 1
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.