Director, Global Regulatory Affairs, Precision Medicine and Digital Health
GSK
Joshua D. Levin brings extensive experience in diagnostic test regulations and FDA Quality Management Systems with over 30 years in the industry. As the Postmarket Team Lead in the Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, CDRH/FDA, Dr. Levin led the review of Quality Management System submissions from companies seeking FDA clearance or approval. He worked with in vitro diagnostic test manufacturers and clinical laboratories to transition their CLIA-based Quality Systems to FDA-compliant frameworks. At FDA, Dr. Levin was also responsible for compliance oversight of molecular pathology, immunology and hematology diagnostic devices.
As Associate Director at PGDx, Dr. Levin spearheaded the transformation of the company's CLIA-based QMS, successfully achieving ISO 13485:2016 certification for PGDx in 2018. At ASELL, Dr. Levin led the company’s regulatory strategy towards Emergency Use Authorization of a novel radiation biodosimetry device. At ASELL and at IronLine Consulting, Dr. Levin guided multiple companies towards FDA clearance and approval, including diagnostic tests for SARS-CoV-2, sepsis and molecular markers for oncology, as well as software-as-a-medical-device (SaMD) products.
In his current role at GlaxoSmithKline (GSK), Dr. Levin leverages his regulatory expertise in healthcare technologies to support GSK’s clinical studies. Dr. Levin holds a BS from Brandeis University and a PhD from Harvard University.
Thursday, October 9, 2025
9:15 AM - 10:30 AM EST