Richard Roy

Richard Roy is a Regulatory and Quality expert from the medical device industry with over 20 years of experience. He led the product development, regulatory and quality functions at multiple organizations such as Nucryt (now Smith & Nephew) and PRIMED Medical Products within the medical device space. He was also a lead consultant at Innomar-Strategies (Cencora), ICON plc (CanReg), and as Principal at GxPRA Consulting, supporting life science companies.

Richard has been involved in the successful regulatory approval for a large number of medical devices spanning Canada, United States, Europe, Australia, Brazil, Mexico etc. This includes low to higher risk devices (e.g., CE Mark, 510(k), medical device licences etc.). 

He is a leader in developing quality management systems and has achieved certifications to standards such as ISO 13485 and ISO 9001. Related to this, he has hosted over 30 regulatory inspections, successfully. 

He holds a Bachelor of Chemical Engineering from McGill University and a Masters in Biotechnology from the University of Toronto. As well as having years of involvement with organizations such as the American Society for Quality (ASQ).

Richard has been heavily involved in the Alberta startup community and sits on the Steering Committee of the Edmonton Regional Innovation Network. He was voted MVP at the 2025 YEG (Edmonton) Startup Community Awards as well as being recognized at the Alberta Legislature for his achievements and contributions.