As Partner, Dawn’s expertise and leadership has helped propel MRC Global’s continued growth as a leading regulatory and compliance consulting firm highly respected throughout the medical device industry. With an extensive background in the medical device and biologics industry that includes VC funded startups, to fortune 100 device manufacturers, Dawn’s depth of experience allows her to develop custom client solutions, go-to strategies for clinical studies and evaluations, and a risk-based approach related to regulatory and quality systems.
Prior to MRC Global, Dawn spent 15 years in the medical device industry working with venture capital backed start-ups and larger companies alike. She focused on regulatory strategy and submissions, along with clinical study design and study execution. Dawn was directly involved with early development and market entry for leading edge medical innovation including magnetic navigation devices for neurosurgical, neurovascular and cardiac indications, high intensity ultrasound for cardiac ablation, recombinant proteins for bone fusion, orthopedic trauma, infusion pumps, and advanced imaging technologies.
Dawn received a Bachelor of Arts in Biological Sciences and Chemistry, and a Masters of Science in Biomedical Sciences from Southern Illinois University at Edwardsville. She is also a certified ISO 13485 lead auditor. As a regulatory, quality, clinical study design expert, Dawn is an industry expert and presents at various trade shows/conferences.