Dr. Levin has many years of experience working with in vitro diagnostics (IVDs), medical devices, clinical laboratory and Quality Management Systems. In his role as Postmarket Team Lead in the Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, CDRH/FDA, Dr. Levin was responsible for overseeing the review of Quality Management System submissions from companies seeking FDA clearance or approval.  In this role Dr. Levin worked with a number of clinical laboratories in the conversion of their CLIA-based Quality System to one that was FDA compliant. 

 

In his roles leading regulatory and quality initiatives in the IVD space, Dr. Levin developed regulatory strategy and quality management systems to support the company's submissions in the US and European Union.   Dr. Levin has experience with leading companion diagnostic initiatives from both the IVD and pharma side and has a deep understanding of the roles of each of these partners and how they can best collaborate on precision medicine initiatives.

 

In his current role as a regulatory/quality consultant, Dr. Levin has worked with over 50 different companies on regulatory strategy, regulatory submissions, and quality management system development.  several clinical labs in upgrading their system to be compliant with FDA.