Background
Prior to MCRA, Alex spent over 6 years performing toxicology and human health risk assessment consulting work as a health scientist, primarily focused on medical devices, consumer products, and electronic nicotine delivery systems (ENDS) devices. Within her role as a health scientist, Alex performed numerous literature reviews, prepared toxicological profiles, and conducted exposure estimates relating to a variety of products. In addition, she has extensive project management experience managing clients in the regulatory, private, and industrial sectors.
Education
Alex received her B.S. from Georgia State University and M.P.H. from Columbia University in Environmental Health Sciences with a Certificate in Toxicology. While at Columbia, Alex worked in a research lab focused on analyzing air quality data from the Environmental Protection Agency (EPA).
Experience
Ms. Alexandra Schulte has 7 years of experience in the scientific consulting field with extensive knowledge of toxicology and human health risk assessment. Alex has performed human health risk assessments on a wide variety of products including medical devices, personal care products, and occupational exposures. She has experience in evaluating biological testing, performing benefit-risk analyses, writing state-of-the-science reviews, and remediating deficiencies from regulatory agencies.
Overview
At MCRA, Alex has proficiency in conducting toxicological risk assessments (TRAs) and rationales according to international standards in support of biocompatibility evaluation of medical devices including cardiovascular, orthopedic, reproductive, and plastic/reconstructive surgery devices.