Profile

Kiran Gulati

Contact Details

United States

Bio

Kiran is the Program Chair at UCSC Silicon Valley for the Regulatory Affairs and Medical Device Certificate programs. 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 13485:2016, CE Mark assessments and FDA 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: Medical Device Quality Systems (ISO 13485:2016/FDA Medical Device Quality System Regulation) 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 the Case for Quality events. She served on the RAPS North American Advisory Board and is currently on the Nominating Committee for the RAPS Board of Directors. http://www.linkedin.com/in/kirangulati

Education

Cal State East BAy
Hayward, California, United States
MBA, 1998
Business Administration

University of California, Berkeley
BS
To 1990

Year Entered Profession

  • 1990-1994

Job History

UCSC Extension Silicon Valley
Program Chair-Regulatory Affairs / Medical Device Certificate Programs
April 2014 - present

Kiran Gulati & Associates
Principal Medical Device Consultant / RAB-Lead Auditor
June 2001 - present

Collagen Corporation/McGhan Medical/Inamed
Quality Management System Compliance
November 1993 - June 2001

Genentech
Quality Control
January 1990 - January 1993

Highest Degree Earned

  • Master’s degree