Tyanne A Pham

14631 Jefferson St, Midway City, CA 92655

Medical Devices

CareFusion - Yorba Linda, CA since Jun 2012
Principal Regulatory Affairs Specialist
Glidewell Dental (Prismatik DentalCraft) Feb 2011 - Jun 2012
RA/QA Specialist
Beckman Coulter Jan 2011 - May 2011
Regulatory Specialist
ev3, Inc. Apr 2005 - Sep 2010
Regulatory Affairs Associate
Micro Therapeutics, Inc. Jan 2003 - Mar 2005
Marketing Coordinator

UCI Extension Course 2008 - 2008
California State University-Long Beach - College of Business Administration 1988 - 1992
Marketing, Business Administration

Medical Devices
Regulatory Affairs
Fda
Iso 13485
Quality System
Iso 14971
Regulatory Submissions
Regulatory Requirements
Quality Control
Product Launch
Capa
Design Control
Validation
Product Development
Ce Marking
Notary Public
Sop
Document Review
U.s. Food and Drug Administration
Corrective and Preventive Action
510K Filing
Global Registration
Sop Creation and Revisions
Rohs
Internal Auditor
Ca Prop 65
Design History
Label Review

English
Vietnamese

Raps (Regulatory Affairs Professional Society)
U.s. Fda Center For Devices and Radiological Health, License 6957673
U.s. Fda Center For Devices and Radiological Health, License 1443567
U.s. Fda Center For Devices and Radiological Health, License 3900023
U.s. Fda Center For Devices and Radiological Health, License 3848209
U.s. Fda Center For Devices and Radiological Health, License 5622014
U.s. Fda Center For Devices and Radiological Health, License 9038736
U.s. Fda Center For Devices and Radiological Health, License 3833306
U.s. Fda Center For Devices and Radiological Health, License 9016493
Noblitt & Rueland
Medical Devices Certificate Program
License 6957673
License 1443567
License 3900023
License 3848209
License 5622014
License 9038736
License 3833306
License 9016493
Auditing Quality Systems For Fda & Iso Compliance
Device Establishment Registration and Listing
Institutional Review Board: Humanitarian Use Devices (Huds)
Overview of Regulatory Requirements: Medical Devices
Computerized Systems Used In Medical Device Clinical Investigations
Good Clinical Practice
Overview of the Premarket Notification Process – 510(K)
Quality System Regulation 21 Cfr 820 Basic Introduction

Principal Regulatory Affairs Specialist at CareFusion

Garden Grove, California

Medical Devices

CareFusion - Yorba Linda, CA since Jun 2012
Principal Regulatory Affairs Specialist
Glidewell Dental (Prismatik DentalCraft) Feb 2011 - Jun 2012
RA/QA Specialist
Beckman Coulter Jan 2011 - May 2011
Regulatory Specialist
ev3, Inc. Apr 2005 - Sep 2010
Regulatory Affairs Associate
Micro Therapeutics, Inc. Jan 2003 - Mar 2005
Marketing Coordinator

UCI Extension Course 2008 - 2008
California State University-Long Beach - College of Business Administration 1988 - 1992
Marketing, Business Administration

Regulatory Affairs
Regulatory Requirements
510k filing
global registration
ISO 13485
internal auditor
Medical Devices
Regulatory Submissions
CE marking
Notary Public
document review
sop creation and revisions

English
Vietnamese

Medical Devices Certificate Program, RAPS (Regulatory Affairs Professional Society)
Device Establishment Registration and Listing, U.S. FDA Center for Devices and Radiological Health
Institutional Review Board: Humanitarian Use Devices (HUDs), U.S. FDA Center for Devices and Radiological Health
Overview of Regulatory Requirements: Medical Devices, U.S. FDA Center for Devices and Radiological Health
Computerized Systems Used in Medical Device Clinical Investigations, U.S. FDA Center for Devices and Radiological Health
Good Clinical Practice, U.S. FDA Center for Devices and Radiological Health
Overview of the Premarket Notification Process – 510(k), U.S. FDA Center for Devices and Radiological Health
Quality System Regulation 21 CFR 820 Basic Introduction, U.S. FDA Center for Devices and Radiological Health
Auditing Quality Systems for FDA & ISO Compliance, Noblitt & Rueland

DJO Global through Real Staffing

Mar 2014 to 2000
Regulatory Affairs Consultant
CareFusion
Yorba Linda, CA
Jun 2012 to Mar 2014
Principal Regulatory Affairs Specialist
Glidewell Dental - Prismatik Dentalcraft
Irvine, CA
Feb 2011 to Jun 2012
Regulatory Affairs & Quality Assurance Specialist
Beckman Coulter
Fullerton, CA
Jan 2011 to Apr 2011
Regulatory Affairs Specialist
ev3 (now Covidien)
Irvine, CA
Mar 2003 to Sep 2010
Regulatory Affairs Associate

California State University
1988 to 1993
Bachelor of Science in Business Administration