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Michael Zapien Location
United States
Michael Zapien Work
Vice President and General Manager, International Clinical, Regulatory and Therapy Development @ (January 2023 - Present)
Vice President Clinical Affairs @ (December 2018 - January 2023)
Senior Director of Clinical Affairs @ (June 2016 - December 2018)
Director, Clinical and Medical Affairs @ CardioDx (April 2016 - May 2016)
Director, Clinical Affairs @ CardioDx (June 2014 - May 2016)
Associate Director, Clinical Affairs @ (November 2013 - May 2014)
Sr. Manager, Clinical Affairs @ Nanostim, Inc. (March 2012 - November 2013)
Consultant, Clinical Research and Regulatory Affairs @ Medi-Globe Corporation (October 2009 - October 2012)
Consultant @ (September 2011 - March 2012)
Marketing Product Manager @ (July 2005 - May 2008)
Clinical Research and Operations Manager @ (January 2003 - July 2005)
Clinical Research Manager @ (March 2000 - January 2003)
Clinical Research Associate @ Cooke Pharma, Inc. (June 1998 - February 2000)
Michael Zapien Education
University of Maryland
Master of Science (Marketing/Marketing Management, General)
2006
San Francisco State University
Bachelor of Science
1995
Michael Zapien Skills
510(k)
CAPA
CE marking
CSRs
Cardiology
Clinical Data Management
Clinical Development
Clinical Monitoring
Clinical Operations
Clinical Research
Clinical Site Management
Clinical Trial Management System (CTMS)
Clinical Trials
Cross-functional Team Leadership
Data Analysis
Design Control
FDA
GCP
IDE
ISO 13485
ISO 14155
Industry standards
Manager of Managers
Medical Devices
PMA
Quality System
Regulatory Affairs
Regulatory Requirements
U.S. Food and Drug Administration (FDA)
Validation
Cross-functional Team...
Class Ii
System Monitoring
Brochures
South Korea
Ultrasound
Responsibility
Publications
Cardiac Surgery
Informatics
ICU
Management
Advertising
Hypercholesterolemia
Strategic Marketing
Independent Contractors
Revisions
Chile
Posters
C
Patient
Hemostasis
Nursing
Slides
New Hires
Contractors
Efficacy
Annual Reports
Investigation
510k
Positioning
Net
Presentations
Budgets
Crfs
Research
Pacific
Cannon
Therapists
Branding
Interventions
Directing
Product Innovation
Catheters
Treatment
Training
Forecasting
Reports
GL
Reporting
Smc
Diagnostics
San Francisco
Coordinated
Intranet
Redwood
Ancillary
Dependent
Internal Audit
Vascular
Safety
Project Planning
Emergency Medicine
Report Writing
Maxwell
Recruiting
Marketing Communications
Regulations
EKG
Brazil
Physiology
Auditing
Sales
Units
ICH guidelines
Belmont
Cross Functional Team
Execution
Contractual Agreements
Closure
Monitors
R
Operations Management
Scheduling
Training Manuals
Patient Care
Writing
Schedules
Physicians
Packaging
Angina
Pricing
Telemetry
Product Launch
Human Resources
Cardiovascular
Injectable
I2
Cross Functional Team Leadership
Medicine
Procedure Manuals
Atlanta
Labor Issues
Customer Requirements
Families
Regulatory Standards
Marketing Management
Product Strategy
Materials
Ctr
Microsoft Word
Stone
Adverse Events
Cros
Coll
Quarter
Guidance
Cardiac
Pad
Trials
Savings
Study Reports
Customer Service
Labelling
Payroll
Supply
Healthcare Management
Product Management
System
Strategy
Sop
Delivery
Cfr
Training Programs
FIX Protocol
Troubleshooting
Distribution
Summit
Sold
Veritas Cluster Server
Diagnose
Vendors
Timelines
Product Training
Michael Zapien Summary
Michael Zapien, based in United States, is currently a Vice President and General Manager, International Clinical, Regulatory and Therapy Development at Ancora Heart, Inc.. Michael Zapien brings experience from previous roles at Ancora Heart, Inc. and CardioDx. Michael Zapien holds a Master of Science in Marketing/Marketing Management, General @ University of Maryland. With a robust skill set that includes 510(k), CAPA, CE marking, CSRs, Cardiology and more. Michael Zapien has 2 emails and 1 mobile phone numbers on RocketReach.
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