Profile

DR Michelle Ragozzino, PhD

Contact Details

United States
Chapter Officer
Bronze Member

Bio

Regulatory affairs professional with broad experience supporting Class II and III cardiovascular and endovascular devices for US, EU, and international markets. Established track record managing and executing high‐quality regulatory submissions, including PMA Annual Reports, 30‐Day Notices, 510(k)s, design dossier renewals, original technical files, and Canadian license amendments and Special Access applications. Creative and results‐oriented leader successful in driving complex projects to on‐time completion. Regulatory core team member on new product development teams, providing regulatory strategy and tactical support throughout the development process. Strong analytical skills and capable of reviewing and interpreting technical data from many sources. Adept reviewer of change management documentation and advertising and promotional materials. Articulate presenter and good writer, with excellent attention to detail.

Education

Massachusetts Institute of Technology
Cambridge, Massachusetts
Ph.D.
Molecular and Cell Biology

University of California, Irvine
Irvine, California
Bachelor of Science
Biological Sciences, Summa Cum Laude, Phi Beta Kappa

Year Entered Profession

  • 2000 - 2004

Job History

Manager, Regulatory Affairs
Milpitas, CA, United States
January 2017 - present

Regulatory Affairs Project Manager
Milpitas, CA
June 2016 - present

Senior Regulatory Affairs Specialist
Fremont, CA
December 2013 - present

Regulatory Affairs Manager
Mountain View, CA, United States
March 2018 - present

Regulatory Affairs Specialist
Santa Clara, CA
September 2012 - November 2013

Regulatory Affairs Contractor
Santa Clara, CA
October 2011 - September 2012

Director, Applied and Natural Sciences Department
Santa Clara, CA
February 2004 - June 2011

Program Director, Sciences and Mathematics
Berkeley, CA
September 1997 - January 2004

Highest Degree Earned

  • Doctoral

Regional Interests

  • US

Product Interests

  • IVDs
  • Medical Devices