Vice President of Regulatory
Leo joins the ShiraTronics team with over 29 years’ experience managing Regulatory Affairs and Quality Assurance groups. Most recently, Leo served as Senior Director of Regulatory Affairs and Quality Assurance at Mainstay Medical, where he authored the PMA used to gain FDA approval for a novel neurostimulation device used for the treatment of mechanical low back pain. Prior to his time at Mainstay, Leo has held leadership positions at Respicardia, Inc., Transoma Medical, Pulmonetic Systems, and Medtronic. His expertise includes IDE and PMA submissions, FDA compliance and Risk Management. Leo holds an MBA from the University of Minnesota, B.S. Degrees in both Electrical Engineering and Chemistry from North Dakota State University and is a Licensed Professional Engineer (P.E.) in Minnesota.