Harikishan Shetty

Background

About Harikishan Shetty

Based in Toronto, Canada, I am a passionate Medtech Regulatory Affairs professional with a robust background in biomedical engineering and product development. With an MS in Regulatory Affairs from Northeastern University, specializing in Medtech, I bring a blend of technical expertise and regulatory knowledge, aiming to drive innovation within the healthcare industry. My journey in the MedTech field has been marked by leading the development and validation of pioneering medical devices such as hemodialysis cartridges, urinary incontinence trainers, and assistive technologies for children with cerebral palsy. These projects not only honed my skills in design and development but also deepened my understanding of the critical regulatory landscapes governing medical products. As a Co-Principal Investigator and founder of startups, I have navigated complex regulatory environments to ensure compliance and market readiness. My experience extends to securing significant grants, managing cross-functional teams, and implementing comprehensive quality assurance systems. I am currently seeking opportunities in Canada’s dynamic medtech sector, where I can leverage my experience and expertise to contribute to technological advancements that improve patient outcomes. I am enthusiastic about the possibility of collaborating on projects that challenge the status quo and make a meaningful impact on society.