Lindsay Bui
Senior Director, Regulatory Counsel @Edwards Lifesciences
Signup · Get unlimited contacts
WORK HISTORY
Senior Director, Regulatory Counsel @Edwards Lifesciences
Irvine, CA, US
Provide legal counsel and guidance to Edwards’ clinical, regulatory, sales, and marketing teams on clinical trials, privacy and data protection, product advertising and promotion, device approvals, False Claims Act and Anti-Kickback Statute compliance, product launches, and other regulatory and commercial issues. Drafted and negotiated a wide variety of clinical and non-clinical agreements, including data licensing agreements, core lab agreements, and HIPAA Business Associate Agreements. Managed the implementation of Master Clinical Trial Agreements across four global business units.Served as lead Legal Regulatory and Privacy Counsel for the Critical Care business unit, and currently serve as Lead Regulatory counsel for the Surgical Structural Heart business unit. Provide primary legal support to the Transcatheter Mitral and Tricuspid Therapies (TMTT) Commercial Cross-Functional Leadership Team, and lead a team of three others providing cross-functional support.
EDUCATION
University of California, Los Angeles
B.A.
The University of Texas School of Law
Juris Doctor (J.D.)
SKILLS
ABOUT LINDSAY BUI
Senior Director, Regulatory Counsel at Edwards Lifesciences
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.