Founder & Principal, SFA Consulting Llc., USA
Founder & Principal, SFA Consulting Llc., USA
Susan Alpert, PhD, MD is currently the principle of SFA Consulting LLC, a one person firm focused on the strategies needed to place medical devices into the global market.
Dr. Alpert joined Medtronic in July 2003 as Vice President of Regulatory Affairs and Compliance. She was Senior Vice President, Global Regulatory Affairs at her retirement in May, 2011 and in this role was responsible for all Medtronic global regulatory policy efforts.
Prior to joining Medtronic, Susan served C.R. Bard, Inc., as Vice President of Regulatory Sciences. She also previously worked at the FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the Director of the Office of Device Evaluation. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.
Susan is on the board of the Society for Women’s Health Research, an organization promoting research on gender differences in health and disease, and has served on the board of the Food Drug Law Institute (FDLI), a forum for the FDA and the legal, business, academic and consumer communities to exchange perspectives on public policy, law and regulation relating to products subject to FDA jurisdiction. She served on the board of advisors for the Medical Technology Leadership Forum (MTLF), an educational organization focused on policy makers, the general public, and the media regarding critical issues affecting the development and adoption of advanced medical technology. In addition, Susan serves on the board of the Women Business Leaders (WBL), an organization of women leaders in the health care sector and on the board of the Minnesota International Center. She is also a past Chair of the Regulatory Affairs Professional Society and a Fellow in that society. Susan served on the Executive Committee of the Clinical Trials Transformation Initiative (CTTI), one of the public/private partnerships working with the FDA to streamline the development of medical products.
Susan completed her undergraduate degree at Barnard College, Columbia University in New York City and holds a master’s degree and PhD in Biomedical Sciences from New York University. She received her medical degree from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York and at Children’s National Health System in Washington, DC.