John Talarico
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von John Talarico
- Current 13 years and 10 months, since Aug 2012
Vice President, Quality and Regulatory Affairs
Topcon America Corporation
Manages and directs all aspects of a Corporate QA, Regulatory and Clinical Affairs Group for Class I and II Ophthalmologic devices. Successful in gaining FDA and international (CE, Japan, Latin America and more) regulatory approvals. Duties includes directing all clinical trial functions and department for research and development of new products.
- 2 years and 4 months, Apr 2010 - Jul 2012
Vice President
Optovue, Inc
Manages and directs all aspects of a Corporate QA, Regulatory and Clinical Affairs Group for Class II Ophthalmologic OCT devices. Successful in gaining FDA and international (CE, Japan, Latin America and more) regulatory approvals. Duties includes directing all clinical trial functions and department for research and development of new products.
- 1 year and 9 months, Jul 2008 - Mar 2010
Sr. VP Regulatory Affairs and Quality Systems
Delcath Systems, Inc
Manages and directs all aspects of a Corporate QA, Regulatory and Clinical Affairs Group for Class III Combination device - oncology drugs company. Successful in gaining FDA IND/IDE Clinical Approvals. Includes directing all clinical trial functions for Investigational Device Exemptions (IDE), Investigation New Drug (IND), 505(b)2 NDA, PMA and CE Mark submissions. Responsible for regulatory compliance, worldwide.
- 2 years and 11 months, Sep 2005 - Jul 2008
VP, QA, Regulatory and Clinical Affairs
ProRhythm
- 1 year and 6 months, Oct 2006 - Mar 2008
Vice President, QA & Regulatory Affairs
Excelsior Medical
- 1 year and 9 months, Jan 2004 - Sep 2005
VP, Regulatory & Clinical
KIKA Medical
- 1 year and 6 months, Aug 2002 - Jan 2004
VP, QA & Regulatory Affairs
EP MedSystems, Inc
- 12 years and 8 months, Jan 1990 - Aug 2002
Sr. Telemedicine Consultant
Bell Labs
Director of QA & Regulatory
E for M Honeywell Medical
QA Engineering Manager
Johnson & Johnson
Ausbildung von John Talarico
Contract Management
Floriday Institute of Technology
Electronics & Mechanical Engineering
Stevens Institute of Technology, Florida Institute of Technology
Sprachen
English
C2 (Verhandlungssicher / Muttersprachlich)
Italian
C1 (Fließend)
Spanish
A1-A2 (Grundkenntnisse)
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