Mgr Regulatory Affairs

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 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

Requirements

• Current knowledge of all laws pertaining to FDA clearance
• 4 Year / Bachelor's Degree

Pay

Min Salary of $112,900 to Max Salary of $181,800 (annual equivalency) DOE