I’m a Senior Manager in Regulatory Affairs who is passionate about driving stratgic regulatory MedTech relationships to tackle new and emerging business challenges. Balancing compliance requirements with sustainable growth is becoming increasingly challenging in today's ever digital markets as we seek to become more competitive in this increasingly regulated global business world.

Areas of Expertise

 

Partner in Strategic Business Planning

Extending External & Regulator Collaboration

Building Bilateral Relationships

Cost-Recovery & Performance Negotiations

Regulatory Achievements

 

Health Canada COVID-19 Interim Order Expanded Indication

Novel Class IV Medical Device Cardiovascular Regulatory Approvals in Canada

Investigational Testing Authorizations of EFS and Pivotal Cardiovascular Studies

Leading a new Regulatory Intelligence and Governance Division

Editorial Advisory Committee at RAPS.org

About Me

 

Charles Tam is a medical device industry professional with nearly 15 years of progressive leadership across regulatory affairs, compliance, and quality in Canada. He is the head of Regulatory Affairs, Intelligence, and Governance as a Senior Manager based at the Canadian head-office of Edwards Lifesciences Inc., a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.

Charles brings a robust cardiovascular medical device specialization in Special Access, Investigational Testing, and high-risk Class IV combination drug & biological tissue implants. Additionally, he also leads the emerging business focus areas of Regulatory Intelligence and Regulatory Governance for both Canada and the international markets (Europe, Middle East, Africa, Latin America, and emerging markets). At the MedTech Canada industry association, he chairs a specialized sub-committee that regularly presents at Health Canada bilateral meetings and holds a seat on the Regulatory Affairs Steering Committee. Charles is also a guest lecturer and Regulatory Affairs Advisor at H2i, the Health Innovation Hub of the Temerty Faculty of Medicine at the University of Toronto. He previously held progressive regulatory roles at Becton-Dickinson, Johnson & Johnson, and Abbott Laboratories. He holds a B.Sc (Honours) from the University of Toronto and a MBA from Ryerson University in Canada.