Team
Divya Gowdar
Consultant
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 achievement and successful contribution in the quality management system, end-to-end product development lifecycle, risk and process management, quality compliance, and manufacturing operations in compliance with US FDA and other international regulations.
Divya strongly believes in making a difference in the quality of patients’ lives and is therefore passionate to work with her clients in identifying challenges, recommending cost-effective solutions and working towards successful outcome in a timely manner. She has provided leadership for strategic projects such as the design and implementation of a Quality Management System (QMS), establish regulatory, quality and compliance strategies for product launch, streamline workflows such as Audit and Inspection Management, Post Market Surveillance, Supplier Management and much more which are in compliance with international regulations including FDA, ISO13485, EU MDD/MDR, and MDSAP.
Academic & Professional Qualifications:
- Master of Science (M.S) — Biomedical Engineering, New Jersey Institute of Technology, Newark, NJ
- Bachelor of Science (B.S) — Instrumentation Technology, Visveswariah Technological University, Karnataka, India
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ASQ Manager of Quality/Organizational Excellence Certification (ASQ CMQ/OE)
- ASQ Certified Quality Engineer (ASQ CQE)
Training, Quality Systems, and Specialties:
- FDA cGMP/QSR, 21 CFR 210, 211, Part 4 Combination Products and ISO13485 quality management systems
- Gap Assessments, Process Development and eQMS implementation
- EU Medical Device Directive and Regulations (EU MDD/MDR) and UK MDR/Brexit/UKCA/Swexit
- MDSAP (Health Canada, US FDA, Japan PMDA, Brazil ANVISA, Australia TGA)
- ISO 14971 and ICH Q9 Risk Management
- Strategic Thinking and Audits/Inspection Management/Mock Audits
- Combination Products Post-Market Surveillance, Device Reporting and Vigilance.
- Competency/Training, Document Control, Supplier Management and CAPA Management
