Lisbert Avila-Yu

An established Quality and Regulatory medtech leader, Lisbert (Lis) Avila-Yu has over 20 years of experience with a focus in new product development of implantable medical devices. Her extensive cardiovascular experience includes senior leadership roles in regulatory compliance and technical review at the British Standards Institute (BSI) and HeartWare (acquired by Medtronic in 2016). As Associate Director of Regulatory at HeartWare, she co-led regulatory efforts to obtain premarket approval (PMA) for a novel vascular assist device (VAD) and secured clinical trial approvals for products in the R&D pipeline. In addition, Ms. Avila-Yu has held multiple quality assurance roles at Cordis Corporation (previously a Johnson and Johnson company) focused on design reliability, process robustness, and quality management system optimization.

Ms. Avila-Yu holds an M.S. degree in Engineering Management and an MBA from Florida International University as well as a B.S. degree in Biomedical & Electrical Engineering from Duke University. Her professional credentials include the RAPS U.S. and European Regulatory Affairs Certifications and ASQ Certified Quality Engineering and Certified Quality Auditor.