Skip to main content
RAPS Convergence 2024 Main banner
Back

Kiran Gulati, MBA, Exemplar Lead Auditor

Program Chair-Regulatory Affairs and Medical Device Quality & Design
UCSC Silicon Valley Extension

Kiran is the Program Chair of the Regulatory Affairs and Medical Device Quality & Design Certificate programs at UCSC Silicon Valley Extension. She is also the Principal Medical Device Consultant at Kiran Gulati & Associates with over 30 years of experience working with medical devices. She is an Exemplar-certified lead auditor and provides companies with guidance with global regulatory compliance strategies. Kiran has assisted a large number of medical device companies with preparing for MDSAP, ISO 13485, EU MDR, Quality Management Systems audits.

She worked at Genentech and McGhan Medical (formerly Collagen Corporation), where she managed the corporate audit functions and led quality management system integration efforts.

She has extensive experience in designing corporate training and has been a speaker at conferences such as the RAPS Regulatory Convergence, the Institute of Validation Technology (IVT) and the ASQ Silicon Valley Division. She is an instructor at UCSC Silicon Valley where she teaches: Quality Systems for Medical Devices: ISO 13485 and FDA Requirements and Conducting Value-Added Audits.

Kiran enjoys volunteering with the local RAPS chapter and was Chair of the San Francisco/Bay Area RAPS Chapter from 2011-2014. She enjoys teaching and mentoring her students and professionals who are aspiring to work in the medical device/biotech industries.

In 2013 and 2014, Kiran collaborated with representatives from CDRH on Case for Quality meetings. She served on the RAPS North American Advisory Board, the Convergence Planning Committee and most recently, on the Nominating Committee for the RAPS Board of Directors.

In August, 2020, Kiran was awarded RAPS Community Leadership Award for her contributions to the regulatory profession.

Presentation(s):