Joshua D. Levin, Ph.D., RAC(US) is the Director of Quality Assurance and Regulatory Affairs at ASELL. Prior to joining ASELL, Dr. Levin was responsible for overseeing quality assurance aspects of the design control and risk management processes at Personal Genome Diagnostics (PGDx), and for achieving ISO 13485:2016 certification for the company’s quality management system. Dr. Levin was previously a reviewer and post market team lead in the Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH, FDA where he was responsible for quality system reviews and compliance activities for IVD products, with a focus on immunology, hematology, and molecular diagnostic devices. Prior to his 8 years at FDA, Dr. Levin worked for 15 years in R&D and process development in various IVD and research products firms. Dr. Levin received his B.A. from Brandeis University and his Ph.D. from Harvard University in Biochemistry and Molecular Biology.