Mike Stelmah BASc, MBA, PMP, RAC

Mike has extensive engineering, regulatory and management experience in medical device and pharmaceuticals industry. He currently leads CMC & Combination Products Regulatory Affairs group and previously created and led Medical Device Development, Manufacturing, Investigations and Human Factors divisions in pharmaceutical industry. His education background is in bioengineering and management, with regulatory, manufacturing and project management certificates. His experience included development and commercialization of medical devices and combination products including auto-injectors, prefilled syringes, patch pumps, safety systems, and vial kits. Mike hired and built strong teams to lead a wide variety of projects to successful approval and launch.