Marielle Lejcher
Vice President, Regulatory Affairs and Quality
Marielle Lejcher, Vice President Regulatory Affairs and Quality, comes to CovarsaDx with more than 20 years of experience, primarily in the area of in vitro diagnostics (IVDs), with risk strategy and FDA policy as her key areas of focus. In addition to providing regulatory strategy to CovarsaDx, Marielle also serves as Vice President at ZoaDx, an animal health CRO focused on advancing animal health to protect human health. Recently, Marielle has consulted at NaviDx, providing strategic Quality and Regulatory services for IVDs. Marielle has significant experience in design and development, quality systems, risk management, biocompatibility, and international and US regulatory affairs and has held a variety of positions at Seegene USA, Fang Consulting, Starkey Laboratories, Beckman Coulter, Viromed, Prevention Genetics, and Barrow Neurological Institute.
Marielle is currently an Adjunct Professor of International Regulatory in the School of Engineering at the University of St. Thomas. Marielle also serves on the Clinical Diagnostics (CDx) Executive Committee and other working groups for the Medical Device Innovation Consortium (MDIC), a non-profit in Arlington, VA dedicated to collaborative efforts to address challenges and accelerate access to technologies by breaking down common barriers.
Marielle holds a B.S. in Kinesiology from Arizona State University and CORe Credential of Readiness (Economics, Accounting, Business Analytics) from the Harvard Business School (HBS).
Marielle is currently an Adjunct Professor of International Regulatory in the School of Engineering at the University of St. Thomas. Marielle also serves on the Clinical Diagnostics (CDx) Executive Committee and other working groups for the Medical Device Innovation Consortium (MDIC), a non-profit in Arlington, VA dedicated to collaborative efforts to address challenges and accelerate access to technologies by breaking down common barriers.
Marielle holds a B.S. in Kinesiology from Arizona State University and CORe Credential of Readiness (Economics, Accounting, Business Analytics) from the Harvard Business School (HBS).