Regulatroy Affairs Group Manager

The Group Manager, Regulatory Affairs, is responsible for writing, submitting and gaining approval of IDE, PMA and 510(k) submissions to the Food and Drug administration (FDA) for class II and class III products.  This position entails being the primary contact with FDA, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with the Product Development teams and the FDA.  This individual must adhere to FDA 21 CFR regulations in all duties. Experience should demonstrate dependability, flexibility and maturity.  Individual must be able to travel at least 10-20% of the time.