Carrara RA/QA Consulting since 2009
President
Genturadx 2010 - 2012
VP Regulatory/Clinical Affairs & Quality
OptiScan Biomedical Corporation 2008 - 2009
Vice President, Regulatory Affairs & Quality Assurance
Inverness Medical Innovations (Cholestech, HemoSense and Oncology SBU) 2007 - Jun 2008
Director RA/Quality
Cholestech Corp 2005 - 2008
Director RA/QA
Education:
St. Mary's College of California
Master of Business Administration (MBA)
University of California, Berkeley
Bachelor of Arts (B.A.)
Skills:
Iso 13485 Fda Strategic Planning Business Planning Mergers Due Diligence Quality Management Regulatory Affairs Quality Assurance Supplier Quality Design Control Verification and Validation Regulatory Submissions Regulatory Policy Regulatory Requirements Cross Functional Team Building Organizational Culture Change Global Regulatory Compliance Change Control Process Excellence Point of Care Clia Waiver Ivd Ivdd Life Sciences Medical Devices Lifesciences Clinical Trials Capa Commercialization Infectious Diseases Validation Quality System V&V U.s. Food and Drug Administration Verification and Validation Corrective and Preventive Action
Languages:
English Spanish
Certifications:
Regulatory Affairs Certification - Us (Rac-Us) Asq Certified Manager of Quality/Organizational Excellence (Cmq/Oe) Regulatory Affairs Professional Society American Society of Quality
Youtube
Romeo and Juliet (Alec R. Costandinos, 1978) ...
Here it is! From beginning to end. All 15 minutes, 24 seconds! Have NO...
Duration:
15m 28s
Mark Knopfler - Romeo and Juliet (A Night In ...
#MarkKnopfler.
Duration:
7m 39s
5/38 Murev Way, Carrara
Located in the pristine complex 'Paradise Palms', a quiet family compl...
Duration:
1m 21s
Dire Straits - Carrara 28/06/1981
Dire Straits - 1981-06-28 - Carrara Mark Knopfler: guitars and vocals ...
Duration:
1h 34m 32s
48/38 Murev Way, Carrara FOR SALE
A hidden gem within the complex - this beautifully maintained 3-bedder...
Duration:
1m 44s
An introduction to Romeo and Juliet (The Roya...
Kenneth MacMillan poignant setting of Sergey Prokofiev's classic score...