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University of Utah Regulatory Affairs Associate in SALT LAKE CITY, Utah

The Regulatory Affairs Associate will support the operations, and strategic planning for regulatory and quality consulting for start-up lifescience based companies coming out of the multifaceted areas or departments within the University and industry. Supports the pre-market regulation process for products requiring governmental action before they can be placed on the market, including filing necessary applications and handling regulatory agency interactions, in particular, but not limited to, US FDA and Notified Bodies. Assists in 3rd party audits of the organizations and contract facilities, and assists in developing procedures to ensure regulatory compliance.