Kamalesh VS

Kamalesh has a background in mechanical engineering and over 10 years of consulting experience in aerospace, industrial HVAC, and medical devices. He started his career designing passenger aircraft, and in 2015 was posted to Japan as a liaison between clients and the work team. After that, he worked for a short time in the industrial HVAC industry, achieving cost reductions throughout the entire process from procurement to shipping. In 2016, he moved to the medical device industry, where he managed regulatory projects (MDD to MDR transition, FDA application) and new product development for an endoscope system. After that, he worked for a short time for a manufacturing company focused on research and development and marketing of new cancer treatments, where he realized there were several critical gaps between the manufacturer's goals and the consulting company's goals, and he keenly felt the need for strong project management to bridge these gaps.

 

He joined MCRA Japan in March 2023 and brings his extensive consulting and management experience to guide clients through the complex environment of Japan's regulatory and medical device markets. He works directly with clients to gain a deep understanding of their goals and provide expert guidance. He coordinates with stakeholders to develop and execute practical plans to navigate the complex approval process in the medical device industry.