Nidhi Gani is a Staff Regulatory Engineer spearheading Software and Product Security of embecta’s flagship product – Diabetes Management System. She also teaches Regulatory Affairs - Product development in digital health and cybersecurity, as an adjunct lecturer at Northeastern University.
She has voiced her expertise in Regulatory Affairs in various medical device conferences around the world:
InnoHEALTH - ‘Make in India Opportunities for Drugs, Biologics and Medical Devices’
Malta Med-tech Summit - ‘Is it time for AI regulations in the MedTech industry’
She is enthusiastic about bringing cutting edge technologies to the world leading her to navigate regulatory pathways for Scandinavian life sciences startups for Gen.era: A Digital Genomic Alliance. She has also contributed her efforts to improve patient health outcomes in the capacity of a Discovery to Delivery (iD2D) Digital Health Fellow- sponsored by the AHA, Verily, AstraZeneca, and Quest Diagnostics.
Her love for the natural world and its relationship with humans led her to pursue Biotechnology Engineering followed by a Master’s in Regulatory Affairs in Drugs, Biologics and Medical Devices.
Throughout her industry experience of 8 years, she has worked for larger corporations, start-ups with a passion for incorporating regulatory process in design and development and postmarket activities to produce safe and effective devices. Her current focus is on medical device cybersecurity and its impact on patient safety and national security.