As a partner, Dawn Norman’s expertise and leadership have been a significant part of MRC Global’s continued growth as a leading regulatory and compliance consulting firm highly respected throughout the medical device industry. With an extensive background of over 25 years in the medical device and biologics industry that includes VC-funded startups to fortune 10 device manufacturers, Norman’s depth of experience allows her to develop custom client solutions, regulatory submission, go-to-market and clinical study strategies, and a client-focused risk-based approach related to regulatory and quality systems. With a focus on regulatory strategy and submissions, along with clinical study design and study execution, Norman has been directly involved with the early development and market entry of numerous, leading edge medical innovations, such as:  AI/ML diagnostic aides, neurovascular- and cardiovascular-based interventional catheters and implants, electrophysiological mapping and novel cardiac ablation, recombinant protein and growth factor-based combination devices, orthopedic trauma, spinal systems, infusion pumps and vascular access accessories, robotic systems, implantable stimulators, light based technologies, dental implants and orthodontia appliances, and advanced imaging technologies, to name a few. Norman received a Bachelor of Arts in Biological Sciences and Chemistry, and a Master of Science in Biomedical Sciences from Southern Illinois University at Edwardsville. She is also a certified ISO 13485 lead auditor. As a regulatory, quality, and clinical study design expert, Norman is a sought-after consultant and speaker for the medical device industry.