Robert E. Lee, MD

Dr. Robert E. Lee brings more than four decades of experience in vascular surgery, clinical research, and regulatory leadership. Most recently serving over 10 years as a Medical Officer on the Vascular & Endovascular Devices Team at the FDA, Dr. Lee played a key role in evaluating and approving breakthrough devices in renal and vascular care.

Vascular Surgeon | Former FDA Medical Officer

His expertise bridges hands-on clinical practice and the regulatory pathways essential to advancing innovation. At the FDA, Dr. Lee helped streamline approval processes and ensure patient safety in the development of next-generation vascular access technologies.

Expertise

Key Roles & Accomplishments

  • Former Medical Officer, U.S. Food & Drug Administration

  • Leader, Vascular & Endovascular Devices Team

  • Oversight of Clinical Trials for Renal Devices

  • Contributor to Global Vascular Surgery Standards

  • Educator & Mentor in Vascular Surgery

  • FDA Regulatory Strategy & Submissions

  • Clinical Trial Oversight

  • Vascular Access Innovation

  • Renal Care & Patient Outcomes