DR. KAITLIN ALEXANDER is a Senior Scientist in the Biomedical Engineering practice at Exponent, Inc. She has expertise in evaluating and providing technical support for regulatory submissions, product development, risk management, and post-market surveillance of medical devices. As a licensed regulatory affairs (RAC-Devices) professional, she uses her knowledge of global regulatory strategy, U.S. FDA regulations, and E.U. directives and regulations to aid in the development of optimal strategies for medical devices, including preparation of submissions and activities throughout the total product lifecycle for Class I, II, and III medical devices. Dr. Alexander is knowledgeable with respect to numerous industry standards and regulations impacting the medical device industry, including ISO 10993, ISO 13485, ISO 14971, and 21 CFR 820. She additionally has experience in protocol development for institutional review board (IRB) and institutional animal care and use committee (IACUC) protocols, evaluation of regulatory submissions and regulatory strategies of biologic/pharmaceutical products, assessment of sterilization processes for medical devices, as well as analysis of the use of digital health technology in the medical device and pharmaceutical industries. Dr. Alexander received a Ph.D. in Biomedical Engineering from the University of Texas at Austin in 2022, a M.S. in Biomedical Engineering from the University of Texas at Dallas in 2020, and a B.S. in Chemical Engineering from the University of Kansas in 2015.