Retired March 2022. Have worked in the Medical Device industry for 33 years. Skilled in regulatory affairs from a submission and compliance perspective as well as quality systems (ISO 13485, CFR 21 Part 820). These skills included both Domestic and International duties. Also skilled in Quality Systems management and compliance. Retired in March 2022 from Kulzer, LLC Dental in South Bend Indiana as Director of Regulatory Affairs and Quality Assurance Responsible for oversight of regulatory affairs, quality assurance/control, documentation center and R&D. Responsible for management/authoring of 510(k) submissions, FDA MDR reporting and daily management of above mentioned groups including department budgets. Responsible for daily managment of product quality regarding manufactured product release, issue resolution, CAPA's, vendors and discrepant product. Quality Management representative for Heraeus Kulzer. Also have overall responsibility for documentation control. Successfully managed ISO 13485, FDA and Health Canada Site quality system audits per ISO, FDA GMP and Health Canada quality requirements. Most recently updated Kulzer's Quality system to ISO 13485 2016, MDSAP and lead a successful audit by registrar. For Kulzer, also helping lead development of a class 1 medical device from a R&D, QA, and RA perspective. Working on software intensive products regarding FDA documentation requirements, risk levels. Have overall responsibility for internal quality system audits. Responsible for monitoring the overall quality system and reporting via organizing and holding periodic management reviews. Prior to Kulzer-Dental worked for Bayer Healthcare for 23 years. Most recent position at Bayer was Manager of Global Regulatory Affairs where I performed product registrations in LA, AP, EU , Canada and USA 510(k) submissions. Planned a PMA. Managed the Latin America market for Bayer Healthcare, Diabetes Care from a Quality and Regulatory perspective.