An experienced Quality and Regulatory Professional, Divya has worked across multiple product portfolios in both large and small medical devices and combination product organizations. She offers a proven track record of successful contribution in the FDA cGMP/QSR, 21 CFR 820, 803, 806, 210, 211, Part 4 Combination Products and ISO13485 quality management systems. She is an expert in end-to-end product development lifecycle, risk and process management (Per ISO 14971 and ICH Q9 Risk Management), Gap Assessments, Process Development and eQMS implementation.
Divya has provided leadership for strategic projects including EU Medical Device Directive and Regulations (EU MDD/MDR) and UK MDR/Brexit/UKCA/Swexit assessments, regulatory, quality and compliance strategies for product launch, streamline workflows such as Audit and Inspection Management, Post Market Surveillance, Supplier Management, Medical Device Reporting, Competency/Training, Document Control, and CAPA Management. She has successfully completed multiple Audits in compliance with Europe, international and MDSAP regulations (Health Canada, US FDA, Japan PMDA, Brazil ANVISA, Australia TGA). Divya is a ISO13485 Certified Lead Auditor (certification pending from BSI next week), Certified Quality Manager of Organizational excellence (CMQ/OE) and Certified Quality Engineer (CQE) from American Society of Quality.
Posted in Who’s Who at EAS.