Over 20 years of Quality and Regulatory Affairs experience in the Pharmaceutical, Medical Devices and Biotechnology space. Project Management experience in implementation of Quality systems compliant to ISO 9000, ISO 13485, MDSAP. Expertise in FDA 483 Objectionable Action correction. Extensive experience in lean management and process improvement in manufacturing, quality, and transactional processes.
Measurements Scientist with master’s in clinical research in Diabetes Care during the COVID 19 pandemic. PhD pursuing in stem technology clinical research with University of California Irvine.