Resumes
Resumes

Principal Consultant
View pageLocation:
2871 Shingle Springs Dr, Shingle Springs, CA 95682
Industry:
Medical Devices
Work:
23andMe - Mountain View, CA since Nov 2011
Director of Regulatory Affairs and Quality Assurance
XDx Aug 2010 - Nov 2011
Director of Regulatory Affairs and Quality Assurance
Novartis Diagnostics May 2006 - Aug 2010
Assoc. Dir., Clinical Operations
Cepheid Apr 2005 - May 2006
Director of Clinical Affairs
InSite Vision Aug 2004 - Apr 2005
Dir. of Regulatory Affairs
Director of Regulatory Affairs and Quality Assurance
XDx Aug 2010 - Nov 2011
Director of Regulatory Affairs and Quality Assurance
Novartis Diagnostics May 2006 - Aug 2010
Assoc. Dir., Clinical Operations
Cepheid Apr 2005 - May 2006
Director of Clinical Affairs
InSite Vision Aug 2004 - Apr 2005
Dir. of Regulatory Affairs
Education:
University of California, San Francisco 1983 - 1986
M.S., Clinical Science California State Polytechnic University-Pomona 1972 - 1976
BS, Microbiology
M.S., Clinical Science California State Polytechnic University-Pomona 1972 - 1976
BS, Microbiology
Skills:
Fda
Biotechnology
Medical Devices
Lifesciences
Clinical Trials
Iso 13485
Regulatory Affairs
Clinical Research
Design Control
Quality System
Pharmaceutical Industry
Clinical Development
Validation
Oncology
Sop
Ivd
R&D
Molecular Diagnostics
Capa
Ctms
Gmp
Regulatory Submissions
Laboratory
Quality Assurance
Hardware Diagnostics
V&V
Assay Development
Gcp
Biopharmaceuticals
Regulatory Requirements
Glp
21 Cfr Part 11
Product Launch
Technology Transfer
Drug Development
Gxp
Commercialization
Personalized Medicine
Medical Diagnostics
Life Sciences
Biotechnology
Medical Devices
Lifesciences
Clinical Trials
Iso 13485
Regulatory Affairs
Clinical Research
Design Control
Quality System
Pharmaceutical Industry
Clinical Development
Validation
Oncology
Sop
Ivd
R&D
Molecular Diagnostics
Capa
Ctms
Gmp
Regulatory Submissions
Laboratory
Quality Assurance
Hardware Diagnostics
V&V
Assay Development
Gcp
Biopharmaceuticals
Regulatory Requirements
Glp
21 Cfr Part 11
Product Launch
Technology Transfer
Drug Development
Gxp
Commercialization
Personalized Medicine
Medical Diagnostics
Life Sciences
Interests:
Transfusion Medicine
Molecular Diagnostics
Personalized Medicine
Ivds
Direct To Consumer Genetic Testing
Molecular Diagnostics
Personalized Medicine
Ivds
Direct To Consumer Genetic Testing