QRAC, LLC @ QRAC LLC, Principal Consultant - Regulatory, quality and clinical consulting for (January 2015 - Present)
Sr. Director, Clinical and Regulatory Affairs @ ShockWave Medical, Inc., (December 2013 - April 2015)
Director QA and RA and CA @ Arstasis, Inc. (March 2010 - December 2013)
Senior Manager Regulatory Affairs @ (August 2005 - March 2010)
Debra Cogan Education
University of Haifa, Israel
B.A. (English Literature)
School of Nursing, Carmel, Haifa, Israel
R.N. (Registered Nurse)
Debra Cogan Skills
Medical Devices
FDA
ISO 13485
CAPA
Regulatory Submissions
Regulatory Affairs
Design Control
Quality System
PMA
V&V
Clinical Trials
GMP
Validation
ISO 14971
Biotechnology
21 CFR Part 11
Change Control
Clinical Development
Clinical Research
GCP
Medical Device Directive
Regulatory Requirements
Clinical Consulting
Leadership
Research
Regulatory
Shockwave
Debra Cogan Summary
Debra Cogan, based in Menlo Park, CA, US, is currently a Vice President, Clinical and Regulatory Affairs at Endovascular Engineering. Debra Cogan brings experience from previous roles at QRAC LLC, Principal Consultant - Regulatory, quality and clinical consulting for, ShockWave Medical, Inc.,, Arstasis, Inc. and Acclarent. Debra Cogan holds a B.A. in English Literature @ University of Haifa, Israel. With a robust skill set that includes Medical Devices, FDA, ISO 13485, CAPA, Regulatory Submissions and more. Debra Cogan has 2 emails and 1 mobile phone numbers on RocketReach.
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