Navnath Kadam

WORK HISTORY

EDUCATION

SKILLS

ABOUT NAVNATH KADAM

Navnath Kadam is a regulatory and quality leader with deep expertise in scaling and sustaining the commercialization of medical technologies across global markets. With over a decade of experience, he specializes in translating complex regulatory requirements into pragmatic, execution‑ready strategies that protect revenue, accelerate geographic expansion, and reduce regulatory risk during high‑growth phases. At OptraSCAN, Navnath leads global regulatory strategy, multi‑regional submissions, and compliance harmonization across the EU, United States, APAC, LATAM, and emerging markets. His work supports the successful commercialization and lifecycle management of digital pathology platforms, imaging systems, LIS‑integrated software, connected medical devices, and AI‑driven diagnostic solutions. He plays a key role in EU IVDR transition and sustainment programs, U.S. FDA submissions, and post‑market change management, enabling uninterrupted market access and portfolio expansion. Prior to OptraSCAN, Navnath held regulatory leadership roles at Philips Image Guided Therapy Corporation and Leica Biosystems, supporting the market expansion ‑up and global lifecycle compliance. He also led the Regulatory Information and Facilitation Center (RIFC) at Venture Center, Pune, advising MedTech and IVD startups on regulatory strategy, design controls, and quality‑system implementation. Navnath holds a Master of Pharmacy in Quality Assurance and Regulatory Affairs and a postgraduate diploma in Entrepreneurship and Business Management. He is a RAPS‑credentialed Regulatory Affairs Professional (RAC–Global) and an ISO 13485 certified Lead Auditor.