Rohit Nehra

Rohit brings over 9 years of experience in regulatory affairs, research and development, and quality assurance, with expertise in global medical device regulatory strategy and compliance.

His experience includes EU MDR, US FDA 510(k), and De Novo submissions, Indian MDR, and regulatory submissions across multiple international markets. Rohit has supported regulatory programs for gastrointestinal and airway stents, GI accessories, and critical care, intensive care, and home care devices. He has worked extensively with regulatory authorities including the EU MDR, US FDA, CDSCO, SFDA, ANVISA, INVIMA, and Thai FDA.

Rohit holds a master’s degree in Innovative Technology Engineering from the Waterford Institute of Technology, Ireland, and is certified as an ISO 13485 Lead Auditor. His combined technical and regulatory expertise enables him to support compliant and efficient market access strategies for medical device manufacturers worldwide.