Harsh Sah

About Harsh Sah

Innovation is the key for evolution. When regulations try to cage it, professionals turn restrictions into revolutions. I am an aspiring regulatory affairs professional, passionate about building a career in Regulatory Affairs since my 2nd year of undergraduate studies, particularly in the MedTech sector. I possess a strong foundation in the Indian Medical Device Rules 2017 (IMDR) and have a solid understanding of the EU MDR 2017/745, and harmonized standards. Additionally, I am an author, educator, public speaker, a member of TOPRA, United Kingdom, and an ex-intern at the IIT Delhi. In my previous work, I was involved in developing a paper-based genosensor for the early detection of antimicrobial resistance (AMR), as well as bacterial and certain viral infections. During this time, I observed a significant gap between companies and regulatory authorities regarding reliability, efficiency, and the ease of doing business. This experience sparked my interest in regulatory affairs within the MedTech sector. With a passion for both science and law, I am driven by the belief that I can help to ensure justice for medical device products through sound regulatory practices.With more then 3 years of theoretical experience, I firmly believe that MedTech is the future, yet the sector lacks passionated regulators. Therefore, I aspire to become a building block in the growing fraternity of Regulatory Affairs. Let’s connect in bringing innovations to life. h••••••••@gmail.com

Experience

1. Assistant Executive Regulatory Affairs

   Auxein Medical

   Jul 2025 — Present · Sonipat, IN