- Ph.D., Biomedical Engineering, University of Texas, Austin, 2022
- M.S., Biomedical Engineering, University of Texas, Dallas, 2020
- B.S., Chemical Engineering, The University of Kansas, 2015
- ISO 13485 Lead Auditor Trained
- Regulatory Affairs Certification (RAC) for Medical Devices
- Cockrell School of Engineering Graduate Fellowship, The University of Texas at Austin, 2021-2022
- Jonsson School Excellence in Education Doctoral Fellowship, The University of Texas at Dallas, 2019-2020
- Outstanding Lecture Teaching Assistant, Biomaterials and Medical Devices, Jonsson School Department of Bioengineering, The University of Texas at Dallas, 2019
- Institute of Electrical and Electronics Engineers (IEEE)
- Biomedical Engineering Society (BMES)
- Regulatory Affairs Professional Society (RAPS)
Dr. Kaitlin Alexander 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, as well as assessment of the use of digital health technology in the medical device and pharmaceutical industries.
Dr. Alexander's background is in biomedical engineering with a focus on human biomechanics, wearable sensors, as well as prosthetic and assistive device technology. She has extensive experience in experimental design, clinical research protocol development, image processing, and machine learning. Additionally, she has experience with ultrasound imaging, computed tomography, image segmentation, computational modeling, and is proficient in MATLAB, Python, and OpenSim. Dr. Alexander's specific research interests involve bridging the disciplines of wearable sensing, biomedical imaging, and human biomechanics to develop robust technologies for prediction and assessment of human movement to improve rehabilitation strategies and devices for individuals with mobility impairments.
Dr. Alexander received a PhD in Biomedical Engineering from the University of Texas at Austin in 2022. While investigating wearable sensing technology for lower-limb assistive device control and assessment, Dr. Alexander developed a novel framework that combined sonomyography, or the evaluation of dynamic ultrasound imaging of skeletal muscle, and machine learning for accurate continuous prediction of human motion. Prior to graduate school, she worked as a clinical research assistant in Physical Medicine and Rehabilitation where she was the clinical coordinator for various industry-sponsored and investigator-initiated clinical trials and observational studies and assisted in the development of image segmentation algorithms to evaluate novel imaging biomarkers to detect the onset and progression of knee osteoarthritis.