Michael Kolber Email & Phone Number
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Michael Kolber Location
- Los Angeles, CA, US
Michael Kolber Work
- Consultant @ Michael Kolber Consulting (January 2000 - Present)
- Vice President, Clinical Affairs and Regulatory Affairs @ (October 2015 - Present)
- Vice President, Clinical and Regulatory Affairs @ (August 2013 - October 2015)
- Vice President, Regulatory Affairs and Quality Assurance @ Paracor Medical, Inc. (April 2003 - April 2012)
- Vice President, Clinical Affairs, Regulatory Affairs and Quality Assurance @ Appriva Medical, Inc. (Acquired by ev3, Inc.) (February 2000 - March 2003)
- Vice President, Regulatory Affairs and Quality Assurance @ (February 1995 - February 2000)
- Manager, Clinical Affairs and Regulatory Affairs @ (January 1985 - January 1995)
Michael Kolber Education
- University of California, Los Angeles
- Mount Saint Mary's University
- San Diego State University
Michael Kolber Skills
- Medical Devices
- FDA
- Regulatory Affairs
- Quality System
- Clinical Trials
- ISO 13485
- Clinical Research
- Quality Assurance
- CAPA
- Biotechnology
- GMP
- Start-ups
- Validation
- PMA
- CE marking
- Commercialization
- Medical Device Directive
- Product Development
- Clinical Affairs
- R&D
- Pre-IDE's
- Quality System...
- FDA Meetings
- Regulatory Strategy...
- Premarket Notifications...
- Special 510(k)'s
- Pre Investigational...
- Investigational Device...
- Investigational Plans
- Clinical Evaluation...
- Dossiers
- Technical Files
- Post Market Surveillance
- Microsoft Office
- Special 510k's
- Refugees
- Planning
- Coronary
- Premarket Notifications 510k's
- Vector
- Design
- Nih
- Regenerative Medicine
- Pivotal
- Surveillance
- Confirmation
- Clinical Evaluation Reports
- Thoracic
- Disease Control
- IDE
- Clinical Data
- Stem Cells
- Strategy
- Clinical Protocols
- Materials
- Accessories
- Keys
- Regulatory Requirements
- Specifications
- Reviews
- Management
- United Nations
- Investigational Device Exemptions
- Pharmaceutical Industry
- Abdominal
- Trials
- Command
- Camp
- STEM
- Regulatory
- Cash
- Treatment
- Institutional
- Cell
- Pre Ide's
- Test Requirements
- Quality System Regulation
- Forms
- Process Improvement
- Patient Recruitment
- Start Ups
- Oversight
- Reserves
- Peace
- Malaria
- Acquisitions
- Prevention
- Business Development
- Military
- Approvals
- Supplements
- Heart Failure
- Summaries
- Literature
- Catheters
- Decision Trees
- Device Design
- Pre Investigational Device Exemption Submissions
- Marketing
- Physicians
- Biocompatibility
- Reliability
- IV
- Promotional
- Regulatory Strategy Development
- Resistance
- Leadership
- Bone Marrow
- Special 510 'S
- Premarket Notifications
Michael Kolber Summary
- Michael Kolber, based in Los Angeles, CA, US, is currently a Consultant at Michael Kolber Consulting. Michael Kolber brings experience from previous roles at Siesta Medical, Inc., BioCardia, Inc., Paracor Medical, Inc. and Appriva Medical, Inc. (Acquired by ev3, Inc.). Michael Kolber holds a University of California, Los Angeles. With a robust skill set that includes Medical Devices, FDA, Regulatory Affairs, Quality System, Clinical Trials and more. Michael Kolber has 1 emails and 1 mobile phone numbers on RocketReach.
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