Stephen A. Leeflang, BS, MBA
Christian S. Eversull, BS, MA, MD
Marybeth Gamber, BA
Marybeth is the Vice President of Regulatory, Compliance, and Quality at AuST. She started her career working for medical device start-up companies in the San Francisco Bay Area crafting and executing regulatory strategies, and creating and maintaining quality systems that were in compliance with US and OUS requirements. She moved to the Boston area where she continued her regulatory, quality, and clinical consulting as an independent consultant for several years before working at Boston Scientific Corporation. Most recently she’s worked at Boston Biomedical Associates developing preclinical, clinical, and strategic regulatory programs for clients.
In the more than 18 years Marybeth has been in the industry, she has provided regulatory and clinical strategic support for a wide range of therapeutic areas, including cardiovascular, neurovascular, peripheral vascular, pulmonary vascular, orthopedics, trauma, gastroenterology, renal, diabetes, obesity, and wound management. She has worked with an extensive range of device types, from intravascular catheters to permanent implants, and has experience in medical device product development process as well as post market surveillance activities. In addition, she has clinical experience including development of study protocols and other study related documents and performing BIMO audits at sponsors and clinical sites in preparation for FDA audits.
Ms. Gamber holds a Bachelor of Arts from Juniata College in English and is a member of the Regulatory Affairs Professional Society.