Regulatory Affairs Professional with more than 20 years experience in medical devices, including in vitro diagnostic devices (IVDs). Skilled in developing global strategies for marketing authorization of Class II and Class III devices. Authored more than 100 cleared 510(k)s. Skilled technical writer with experience in development and review of labeling including, instructions for use and marketing materials. Regulatory process development and management experience including change assessment for reporting, letters to file, vigilance reporting, inspections​/​audits, licensing​/​registration​/​listings, and more!