AFDO RAPS Healthcare Products Collaborative
BIO
Denny

Dennett F.

Kouri

Senior Vice President, Corporate Quality, Regulatory and Clinical

Edwards Lifesciences

Denny Kouri is Senior Vice President, Corporate Quality, Regulatory and Clinical at Edwards Lifesciences. In this role, he leads the development and implementation of Edwards’ risk-based requirements in these areas, working in partnership with Global Operations to support operations, customers and patient-focused product development. Over his 20 years with Edwards, Denny has helped shape the company’s global regulatory and quality strategy, including the establishment of Edwards’ Corporate Regulatory organization and global strategy for regulatory agency inspections. He has deep experience engaging with government agencies and external regulatory bodies, building productive relationships that support quality, regulatory alignment and operational excellence. Under his leadership, Edwards has maintained a strong external inspection track record over the past decade. Denny also oversees supplier management and software validation capabilities and provides leadership and assessment support for alliance management and business development due diligence. He holds a bachelor’s degree in political science from the University of California, Santa Barbara, and a law degree from Southwestern

About AFDO/RAPS Healthcare Products Collaborative

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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