John Talarico
Angestellt, Vice President, Quality and Regulatory Affairs, Topcon America Corporation
Oakland, Vereinigte Staaten
Werdegang
Berufserfahrung von John Talarico
Bis heute 11 Jahre und 10 Monate, seit 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 Jahre und 4 Monate, Apr. 2010 - Juli 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 Jahr und 9 Monate, Juli 2008 - März 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 Jahre und 11 Monate, Sep. 2005 - Juli 2008
VP, QA, Regulatory and Clinical Affairs
ProRhythm
1 Jahr und 6 Monate, Okt. 2006 - März 2008
Vice President, QA & Regulatory Affairs
Excelsior Medical
1 Jahr und 9 Monate, Jan. 2004 - Sep. 2005
VP, Regulatory & Clinical
KIKA Medical
1 Jahr und 6 Monate, Aug. 2002 - Jan. 2004
VP, QA & Regulatory Affairs
EP MedSystems, Inc
12 Jahre und 8 Monate, Jan. 1990 - Aug. 2002
Sr. Telemedicine Consultant
Bell Labs
Director of QA & Regulatory
E for M Honeywell Medical
Ausbildung von John Talarico
Contract Management
Floriday Institute of Technology
Electronics & Mechanical Engineering
Stevens Institute of Technology, Florida Institute of Technology
Sprachen
Englisch
Muttersprache
Italienisch
Fließend
Spanisch
Grundlagen