A rapidly growing, molecular diagnostic company in Madison, Wisconsin is looking for a Director of Regulatory Affairs. The person in this position is responsible for leading the activities of the Regulatory Affairs (RA) team with emphasis on regulatory strategy and preparation, review, and submission of regulatory documentation for medical devices and in vitro diagnostics (IVD).
Location: Madison, WI
- Identify and develop new regulatory policies, processes and SOPs
- Provide current regulatory intelligence and formulate regulatory strategy
- Oversee implemention of activities to secure regulatory approval of new products
- Serve as principal interface with reviewers from FDA and other regulatory authorities
- Supervise employee performance and develop career growth plan