Director, QA/RA/CA
MediView XR
Bring in-depth industry knowledge as an experienced regulatory and quality professional with progressive experience in the medical device industry. Experience spans across a variety of roles within the orthopedic, cardiovascular, image guided therapy, radiology, ophthalmic, and augmented reality industries including regulatory affairs, regulatory compliance, regulatory intelligence, quality compliance, and quality management systems. Developed strategies to bring companies into compliance with ISO 13485:2016 and the EU Medical Device Regulation, prepared companies for their MDSAP audits, led companies through successful FDA inspections and Notified Body audits, successfully merged acquired organizations into the parent company, and implemented initial quality management systems. Developed global regulatory strategies aligning with the business needs and authored global submissions for medical devices in the US, EU, Canada, Brazil, Japan, China, Israel, Australia, Taiwan, South Korea, Saudi Arabia, South Africa, and many more.
Disclosure information not submitted.
Tuesday, September 13, 2022
11:15 AM – 11:45 AM MST