Denny Kouri stands at the forefront of leadership, responsible for
developing and implementing Edwards Lifesciences’ Quality, Regulatory,
and Clinical requirements in partnership with Global Operations. Over the
past six years, he has established Edwards’ Corporate Regulatory
organization, ensuring adherence to global regulations and standards,
addressing key issues that impact operations, customers, and patients. For
the past two years, Denny has also overseen the Supplier Quality
Organization, supporting Edwards’ overall Supplier Management strategy

and leading the charge with his Operations partners to establish best-in-
class supplier management capabilities.

Demonstrating deep regulatory inspection knowledge, both internally and
externally, Denny has established the global strategy and requirements for

all regulatory agency inspections, including Pre-Approval Inspections, Post-
Approval, Notified Body, and Bioresearch Monitoring inspections. Under his

leadership, Edwards has received no critical observations from external
regulators in the past seven years.
Throughout his 18-year tenure with Edwards, Denny has built a reputation
for developing business strategies and maintaining excellent external
communications. He was the main point of contact and responsible for the
strategy and management of all activities under the second variance
granted by the FDA, ensuring patients had access to Edwards THV
products while addressing device quality system requirements.
In addition to his regulatory and quality responsibilities, Denny oversees the
Software Quality Organization supporting Enterprise System capabilities
and SW Validation process ownership for equipment utilized in operations.
He also engages with Edwards’ Business Development organization in all
Alliance Management and Due Diligence activities, providing the required
quality leadership and assessment support.

Denny holds a bachelor’s degree in political science from the University of
California, Santa Barbara, and a law degree from Southwestern University
School of Law in Los Angeles. He was admitted to the State Bar in 1994
and has held various significant roles throughout his career, including
Litigation Associate at Meserve, Mumper & Hughes LLP, and Director of
Regulatory and Legal Compliance at Grifols, Inc.