Linda M.
About Linda M.
Linda M. is a Regulatory Affairs Specialist with over 10 years of experience in cancer nanomedicine and drug development. She has held positions at notable institutions including Brigham and Women's Hospital and TransMedics, Inc., and holds advanced degrees in Regulatory Affairs and Analytical Chemistry.
Current Role at TransMedics
Linda M. serves as a Regulatory Affairs Specialist at TransMedics, Inc. since 2021. In this role, she applies her extensive knowledge of regulatory frameworks to ensure compliance with US, EU, and international premarket and postmarket requirements for drugs, biologics, and medical devices. Her expertise contributes to the organization's mission in advancing medical technology and improving patient outcomes.
Previous Experience at Brigham and Women's Hospital
Linda M. worked as a Research Specialist at Brigham and Women's Hospital from 2015 to 2018. During her three years in the Greater Boston Area, she engaged in various research projects, contributing to advancements in medical research. This position laid the groundwork for her subsequent roles in the field of regulatory affairs and research.
Education and Expertise in Regulatory Affairs
Linda M. holds a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. She also earned a Ph.D. in Analytical Chemistry from Duke University and a Bachelor of Engineering from Tianjin University. Her educational background equips her with a solid foundation in both regulatory science and analytical techniques, enhancing her effectiveness in her current role.
Research Experience and Contributions
Linda M. has over 10 years of experience in cancer nanomedicine, biomolecule characterization, and drug delivery. She has served as the principal investigator for two research grants and co-principal investigator for three others. Her experience includes managing research groups and training students and junior scientists, highlighting her leadership in scientific research.
Publications and Patents
Linda M. has published more than 40 papers in scientific journals and has disclosed numerous patents throughout her career. Her contributions to the field of regulatory affairs and research are documented in her publications, reflecting her commitment to advancing knowledge and innovation in medical science.