Position:
Director, Regulatory Affairs at Beckman Coulter
Location:
North Richland Hills, Texas
Work:
Beckman Coulter
since Aug 2009
-
Director, Regulatory Affairs
Olympus America Inc.
Jul 2005 - Nov 2009
-
Senior Manager, RA/QA
Clarient
Apr 1997 - Jun 2005
-
Director, Regulatory Affairs & Quality Services
Surgin Surgical Instrumentation
Mar 1995 - Apr 1997
-
Design Engineer
Optimed Technologies
Aug 1992 - Mar 1995
-
Quality Engineer
Education:
ITT Technical Institute 1989 - 1991
AAS, CAD
Mt. San Antonio College 1985 - 1986
Skills:
Medical Devices, Quality System, FDA, ISO 14971, CMDCAS, CMDR, Quality System Compliance, Part 820, Post Market Surveillance, Adverse Event Reporting, Regulatory Strategy Development, Technical Files, Class III Medical Devices, IVDD, IVD
Honor & Awards:
R.A.C. Certification - Regulatory Affairs Professional Society
Lead Auditor / Assessor Training - Stat-A-Matrix
ISO13485:2003; ISO14971 - Underwriters Laboratories
ISO9000:1994 (2000) - TUV Management Service
Medical Product Development - University of California, Irvine