Drishya Nair

Drishya is a Manager with EY’s Enterprise Risk Quality & Compliance practice. She has close to 10 years’ experience in Business roles and in supporting DIgital Transformations in the quality and regulatory space for Life Sciences clients. Her knowledge and expertise is in leading seamless QMS process improvements based on HIPAA and 21 Code of Federal Regulations (CFR) Part 820 requirements, end-to-end Medical Device Regulatory compliance operations & global submissions. She also has hands on experience in managing end to end Quality system process and technology improvement for Pharma/Med device/IVDs Biotech companies. She has extensive experience in prepping and facilitating regulatory body audits including FDA & Notified body Audits, authoring Regulatory Strategies for new and enhanced medical device products as well as helping companies comply to regulatory requirements through M&A periods and changing regulatory requirements in markets like US, Europe, Canada, Brazil, Australia, China and Japan. Drishya holds a Master’s degree in Biomedical Engineering from University of Texas at Dallas and a Bachelor’s in Biotechnology Engineering from VIT University, India. She is a member of the ISPE Drug Shortages Initiative working group.