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