My Profile

MR Thomas Navarro, RAC

Contact Details

United States

Bio

Consultant for Global Regulatory Affairs Project Management in the San Francisco Bay Area. Regulatory Affairs Certification (RAC - U.S. ) Project and Program Management Certificate (UC Santa Cruz 2016) Regulatory Affairs Certificate (UC Santa Cruz 2012) SPECIALTIES: Class II 510k and Class III PMA Device Submissions, International Device Registrations, EU Technical Files and Design Dossier, Design Change Control Board member, Post-Market Reporting, Field Corrections and Device Recalls, Facility Inspection Preparation and Notified Body Audit, RoHS and WEEE Compliance, Product Labeling Review, Risk Management, FDA Advisory Panel Preparation

Education

University of California @ Santa Cruz
California, United States
Certificate in Regulatory Affairs

Year Entered Profession

  • 1995 - 1999

Current Organization Type

  • Consulting Firm

Job History

Regulatory Affairs Project Consultant
San Francisco, CA, United States
present

Regional Interests

  • Asean
  • Canada
  • China
  • Europe
  • Latin America/Carribean
  • Oceania
  • US
  • Worldwide

Product Interests

  • Combination Products
  • IVDs
  • Medical Devices

Product Interests

  • Combination Products
  • IVDs
  • Medical Devices

Regional Interests

  • Asean
  • Canada
  • China
  • Europe
  • Latin America/Carribean
  • Oceania
  • US
  • Worldwide

Year Entered Profession

  • 1995 - 1999

Current Organization Type

  • Consulting Firm