Background
Dr. Scott specialized in peripheral interventional devices in the cardiovascular space, including stents and scaffolds indicated for below-the-knee applications, associated interventional devices systems (catheters, introducers, guidewires, valvulotomes, etc.), embolic devices (solid and liquid), and combination products such as drug-coating scaffolds and balloons. Additionally, Dr. Scott specializes in all pre-clinical review and analysis, including biocompatibility testing.
Education
Dr. Scott received a B.Sc. in Biomedical from Saint Louis University and a Ph.D. in Biomedical Engineering from Viriginia Commonwealth University.
Experience
Dr. Scott worked for 4 years in the Division of Peripheral Interventional Devices within the Office of Cardiovascular Devices at FDA. While there, she served as a Team Lead, Lead Reviewer, Biocompatibility Subject Matter Expert, and MDR reviewer. She began her regulatory work leading the review of below-the-knee, drug-eluting, bioresorbable scaffolds, and expanding into the iliac, superficial femoral artery, carotid and coronary spaces. Additionally, Dr. Scott has experience with associated delivery systems and interventional devices, embolics, embolic protection devices, and balloon catheters.
Overview
Dr. Scott supports regulatory strategy and submission. Her primary roles include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies.