Janice Kruse serves in a consulting capacity as Senior Director of Regulatory Affairs and Quality Assurance for TransMed7.
Janice has over 25 years of experience in research and development of investigational medical devices, human pharmaceuticals, and biologics. She has held management positions of increasing responsibility at the major manufacturing firms of Medtronic and Bristol Myers Pharmaceuticals.
Janice is the founder of a regulatory consulting group providing clinical, regulatory, and quality services to the regulated health care industry in the United States, Europe, Canada, Asia Pacific, and Latin America. Her expertise includes creative thinking to effectively solve complex challenges, technical leadership, and vision in preparing regulatory submissions for Class II, III and IV medical devices. She has successfully obtained market clearances and approvals for medical devices as well as biotechnology products from FDA, PMDA, Health Canada, Notified Bodies, and other local regulatory bodies.
Janice’s experience includes establishing Quality and Clinical Systems for manufacturers to perform activities according to the regulations and standards for the pre-market design, development, and testing of medical devices as well as post-market surveillance of medical devices.
Janice’s client list includes several multi-billion dollar medical device manufacturers and pharmaceutical firms as well as small start-up medical device and biotechnology firms and physicians with sole inventions. Her services include providing regulatory strategies and authoring regulatory submissions; managing feasibility IDE studies; auditing of Clinical and Quality systems of Sponsors, Core Labs, CROs, and Principal Investigators; and GxP and Quality System Regulation (QSR) training for her clients.
Janice obtained a Bachelor of Science degree in Dietetics from Iowa State University and has completed Biomedical Engineering graduate level courses at the University of Minnesota-Twin Cities campus. Her credentials include Registered Dietitian Nutritionist and certification in clinical regulatory knowledge.