Michale Oaks has extensive experience in Global Distribution of Medical Devices, which includes success in sales and business development, building strong relationships with manufacturers, customers, and partners for mutually beneficial growth. Specialties include Develop/implement regulatory strategies for start-up companies via a “right fit” regulatory pathway.
Instrumental in Develop/manage communications with regulatory agencies (US FDA and Health Canada).
Lead development of clinical study design, including site recruitment and assessment, and study management. In addition implement Design Control and Risk Management Programs for business efficiencies to assure that source documents support of regulatory submissions and long-term compliance.