Mary Vater

Mary Vater is an accomplished professional in regulatory affairs and quality assurance within the medical device industry. Currently serving as the Director of Regulatory Affairs at Innolitics since April 2024, Mary has also held positions as a Senior Regulatory Affairs Project Manager. Additionally, Mary contributes as faculty at AAMI, where responsibilities include developing and teaching training courses related to ISO 13485, 21 CFR 820 auditing, and the 510(k) and De Novo processes. Previous experience encompasses consulting on FDA 510(k) submissions at Medical Device Academy, Inc. and leading Quality Assurance at Biomedical Devices of Kansas. Mary holds a Bachelor of Science in Bioengineering from Wichita State University and is an ISO 13485 Certified Lead Auditor with extensive expertise in medical device software development and risk management practices.