Margeaux has over 8 years of experience and expertise in biomedical research and regulatory/ clinical experience. 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 orthopedic, spine and cardiovascular. As Director of Regulatory Affairs, she specializes 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.
Since joining MCRA in 2013, 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. She also specializes in development of international regulatory submissions including, regulation-compliant Clinical Evaluation Reports, comprehensive literature evaluations, and manuscript submissions. She also conducted research on medical devices as well as designed and implemented mechanical, biomechanical, animal testing, and clinical study strategies to 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).
Prior to joining MCRA, Margeaux received her Bachelor of Science and Master of Science in Bioengineering at Clemson University.