Lindsay Bui

Experience

1. Senior Director, Regulatory Counsel

   Edwards Lifesciences

   Nov 2023 — Present · 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

• Public Policy
• Privacy Law
• Conflict Resolution
• Microsoft Office
• Marketing
• Community Development
• Legislative Relations
• Westlaw
• Research
• Teaching
• Legal Research
• Event Planning
• Government
• Nonprofits
• Public Speaking
• Nonprofit Organizations
• Legal Writing
• Trials
• Criminal Law