Margeaux Rogers has over 10 years of experience and expertise in regulatory/ clinical strategy and biomedical research. Since joining MCRA in 2013, Margeaux has secured pre-market approval (PMA) or panel-track PMA supplement approval for 5 novel orthopedic and spinal devices, including FDA Advisory Panel meetings for 3 of these products, managed PMA development teams, including regulatory agency interactions, clinical data analysis, and statistical strategy and led strategy and FDA interactions for numerous novel medical devices. As Vice President of Spine Regulatory Affairs, she leads MCRA’s spine team in development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials, and regulatory strategy for medical devices.
She has an extensive background in developing and implementing path-to-market strategies, regulatory submissions, and clinical programs for a wide array of therapeutic technologies. She is an accomplished clinical and regulatory technical writer and has experience in development and implementation of clinical protocols, regulatory strategy, and regulatory submissions in therapeutic areas including spine, orthopedics and oncology. Margeaux has developed and reviewed US regulatory submissions for medical devices including 510(k)s, PMAs, IDEs, and various Pre-Submissions including Breakthrough Device Designation requests as well as international regulatory submissions including, regulation-compliant Clinical Evaluation Reports, comprehensive literature evaluations, and manuscript submissions. She has also conducted research on medical devices as well as designed and implemented mechanical, biomechanical, animal testing, and clinical study strategies for orthopedic and spinal companies. Margeaux also leads MCRA’s advisory committee services, where she provides management and support and management Clinical Safety Monitoring Committees (DSMBs and CECs).
Margeaux received her Bachelor of Science and Master of Science in Bioengineering at Clemson University. In addition, she received Regulatory Affairs Certification from the Regulatory Affairs Professional Society (RAPS).