Marielle Lejcher brings over 20 years of expertise in diagnostic product development, with a focus on risk strategy and FDA policy to advance animal health and its critical connections to human health. Her strategic insight and regulatory acumen have positioned her as a leader in quality systems, risk management, biocompatibility, and both U.S. and international regulatory affairs.
Marielle recently served as a consultant at NaviDx, providing high-impact Quality and Regulatory strategies for diagnostic products. She has also held key roles at Seegene USA, Fang Consulting, Starkey Laboratories, Beckman Coulter, Viromed, Prevention Genetics, and the Barrow Neurological Institute, where she contributed to groundbreaking advancements across diverse areas of healthcare innovation.
Marielle is an Adjunct Professor of International Regulatory in the School of Engineering at the University of St. Thomas, where she mentors future leaders in regulatory science. She also serves on the Clinical Diagnostics (CDx) Executive Committee and other working groups for the Medical Device Innovation Consortium (MDIC), a nonprofit dedicated to accelerating access to healthcare technologies through collaboration and innovation.
She earned a Bachelor of Science in Kinesiology from Arizona State University and holds the CORe Credential of Readiness in Economics, Accounting, and Business Analytics from Harvard Business School. Her depth of knowledge, industry leadership, and dedication to advancing health solutions make her an invaluable part of the ZoaDx team.