Anupam brings with him two decades of experience in product development, product lifecycle management, Regulatory Affairs and Quality Assurance at large  diagnostic companies (Roche Molecular Diagnostics, Thermo Fisher, Becton Dickinson), mid-size and smaller IVD companies as well as at global consulting companies such as Alten Group and HCL Technologies. He has been working at a Senior Director level in Regulatory & Quality functions for the past few years, taking up business critical roles such as Management Representative of Quality (MRQ), Person Responsible for Regulatory Compliance (PRRC), Regulatory Submission Adviser, Practice Head and Delivery Lead of a Regulatory Center of Excellence . In these roles, he has provided strategic leadership and guidance, also led cross-functional initiatives involving RA/QA, Development, Product Management, Clinical Operations, Medical Affairs, PMO and Executive Leadership. His broad expertise includes IVDR and MDR driven transition planning and implementation, various types of Regulatory submissions with US-FDA and EU Notified Bodies, international product registration, diagnostic product Quality Control and performance evaluation, QMS assessment and implementation in compliance with international standards and regulations, as well as different types of Quality audits. On the educational front, Anupam has offered Regulatory training programs to working professionals and graduate students in several US Universities and has been a Guest Lecturer in academic institutes.