Director, Regulatory Affairs & Quality Assurance - (Madison, WI)

Summary of Major Responsibilities Reporting to the Vice President of Clinical and Regulatory, the Director of Regulatory Affairs & Quality Assurance is responsible for leading the activities of the Regulatory Affairs and Quality Assurance. This role will lead the strategy and the preparation, review and submission of documents to FDA and other national authorities and oversight of the Quality Management System (QMS), including post-market surveillance, document control and internal auditing. The Director, Regulatory Affairs & Quality Assurance is also the named Management Representative for the QMS. This role must be able to combine knowledge of scientific, regulatory and business issues to assure that products are developed, manufactured, and distributed according to all national, regional, and local laws and regulation pertinent to the manufacture and distribution of medical devices and/or IVDs.