Introduction
Marielle Lejcher is the Program Director of the M.S. in Regulatory Science program at the University of St. Thomas. Ms. Lejcher has experience as an instructor for the University of St. Thomas College of Engineering in the area of regulatory affairs for medical devices. Marielle has significant experience in design and development, quality systems, risk management, biocompatibility, clinical research and international and US regulatory affairs.
Ms. Lejcher is an accomplished quality and regulatory leader with more than 20 years of experience in medical devices and in vitro diagnostics, with risk strategy and FDA policy as her key areas of focus. She has held senior leadership positions with a number of large and small medical device companies, as well as providing consulting services to medical device and biotechnology companies. Her expertise extends across many therapeutic areas, including respiratory, blood virus, infectious disease, cardiovascular, reproductive health, cancer oncology, glucose/HbA1c, toxicology, generative AI for chronic disease, and neurodegenerative disease.
Courses taught at St. Thomas:
- ETLS 880 Regulatory Science Project
- ETLS 720 Physiology and Medical Devices
- ETLS 737-International Regulatory Affairs for Medical Devices-Tier 1 Countries
- ETLS 738-International Regulatory Affairs for Medical Devices-Tier 2 Countries