Mgr Regulatory Affairs

Participate in the planning of meetings between the FDA and CMSU regarding regulatory issues as assigned by the Director, Regulatory Affairs Provide guidance to CINC 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 CINC employees on regulatory items Audit CMSU's policies and procedures, as required Submit and track pending FDA submissions (510(k)s, PMAs), IDE, and IRB, as applicable