**Mgr Regulatory Affairs - req1336** **OVERVIEW** Responsible for pre-market activities and support of post-market team as assigned by the Director, Regulatory Affairs to include new product planning and remedial actions on released products. Participate in trade association activities to ensure that the interests of Canon are represented. Provide input and assist in determining the appropriate regulatory strategies for product clearance. **RESPONSIBILITIES** + Participate in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by the Director, Regulatory Affairs. + Provide guidance to CMSC Business Unit Managers and Engineering Managers in pre-market submission preparation. + Support activities related to FDA compliance activities including GMP inspections, recalls and MDR's as assigned by the Director, Regulatory Affairs. + Support legal actions as required by the legal department or directed by the Director, Regulatory Affairs. + Support training/development of RA staff. + Provide training to CMSU and CMSC employees on regulatory items. + Audit CMSU's policies and procedures, as required. + Submit and track pending FDA submissions (510K's, PMAs), IDE, and IRB, as applicable. **QUALIFICATIONS** + Current knowledge of all laws pertaining to FDA clearance. + 4 Year/Bachelor’s Degree in regulatory, engineering, orphysical sciences. + 5 years Direct FDA experience. + Will work PST hours, prefer candidate to reside on the West Coast. Potential in-person meetings 1x per month or so. + Range in $130,000 base salary plus performance incentive with upside potential. DOE. \#LI-RS1 \#LI-Remote **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions. Canon Medical Systems offers a competitive salary and benefits package, we support a diverse workplace and are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, sexual orientation, gender identity, religion, national origin, protected veteran status, or on the basis of disability. We invite you to join and become part of our Canon family._