Dr. Gopal P. Mohanty is a seasoned industry executive and an educator with over two decades of global leadership in Quality, Compliance, Regulatory, and Clinical Affairs.
He has held pivotal roles, including Vice President, Director, and Advisory Board Member, driving strategic initiatives and operational excellence across multinational organizations.
Dr. Mohanty has a proven track record of driving efficiency in regulatory submissions, securing product approvals, and ensuring compliance with global standards, including FDA, EU, PMDA, and other regulatory bodies. His accomplishments include spearheading global quality and regulatory strategies, launching products in the USA, EU, and MDSAP regions, and implementing robust systems compliant with FDA, ISO 13485, MDSAP, MDR, and SaMD standards.
He has taught various topics related to Regulatory Science, Quality, Compliance, and Lean Manufacturing as an adjunct faculty at several institutions over the past 20 years. He has successfully led transformative initiatives, delivering millions in savings through Six Sigma projects and significantly improving quality across complex product platforms.
Dr. Mohanty holds a Ph.D. in Industrial Engineering complemented by executive education at Harvard, Kellogg, and Chicago Business Schools. A certified ISO 13485 Lead Auditor and Six Sigma Black Belt, he also holds dual Regulatory Affairs certifications in medical devices and pharmaceuticals. His unique blend of technical expertise and strategic vision empowers him to inspire teams, align stakeholders, and deliver innovative solutions that drive organizational success.