Randy Vader Email & Phone Number
Senior Vice President, Regulatory and Quality Affairs @ FUJIFILM Medical Systems U.S.A., Inc.
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Randy Vader Location
- United States
Randy Vader Work
- Senior Vice President, Regulatory and Quality Affairs @ (February 2017 - Present)
- Senior Vice President, Quality, Regulatory and Clinical Affairs @ FDA Compliance Group (October 2014 - Present)
- Vice President, Quality and Regulatory Affairs @ (June 2012 - October 2014)
- Vice President, Clinical and Regulatory Affairs @ Predictive Biosciences (December 2010 - December 2011)
- Senior Vice President, Quality, Regulatory and Clinical Affairs @ (December 2009 - December 2010)
- Vice President, Quality, Regulatory and Clinical Affairs @ (March 2008 - June 2010)
- Lead Director, Quality and Regulatory Affairs @ PHILIPS Healthcare (September 2002 - March 2008)
Randy Vader Education
- San Diego State University
Bachelor of Science - BS
Randy Vader Skills
- 21 CFR Part 11
- Biochemistry
- Biomedical Engineering
- Biopharmaceuticals
- Biotechnology
- CAPA
- Cancer
- Capital Equipment
- Cardiology
- Clinical Development
- Clinical Research
- Clinical Trials
- Commercialization
- Cross-functional Team Leadership
- Design Control
- EMEA
- European Union
- FDA
- GLP
- GMP
- Genomics
- Global Marketing
- Hardware Diagnostics
- Hospitals
- ISO 13485
- IVD
- Immunology
- In Vitro
- Infectious Diseases
- Laboratory
- Lifesciences
- Market Development
- Medical Devices
- Medical Diagnostics
- Medicine
- Microbiology
- Molecular Biology
- Oncology
- Orthopedic
- Pharmaceutical Industry
- Product Launch
- Quality Assurance
- Quality Control
- Quality System
- R&D
- Regulatory Affairs
- Sop
- Technology Transfer
- V&V
- Validation
- Project Management
- Marketing
- Cross Functional Team
- Regulatory Requirements
- Cross Functional Team Leadership
- Clinical Affairs
- Regulatory
- Regulatory Approvals
- ELISA
- ISO
- Information Technology
- Philips
- Software Development
- Document Management
- NGS
- Pets
- Scanners
- ISO 14971
- Product Safety
- Board of Directors
- Herpes
- Raps
- Regulations
- Diagnostics
- Advertising Agency
- Regulatory Agencies
- Change Control
- Approvals
- Fusion
- Virus
- Stability
- Strategic Planning
- Cypress
- Executive Team
- Communication
- Digital Imaging
- Resume
- Data Profiling
- Product Clearance
- Localization
- DNA sequencing
- FIX Protocol
- Biology
- Auditory
- Tests
- Bridge Inspection
- Test Systems
- Legal Affairs
- Market Launch
- Fish
- ASQ
- Accreditations
- Immunohistochemistry
- IDE
- Negotiation
- Laboratory Medicine
- HIPAA
- Business Development
- Engaging
- Compliance
- Supplier Quality
- Clinical Research Associates
- Treatment Planning
- Brazil
- Monitors
- Overseeing
- CAP
- China
- MRI
- Coordination
- Execution
- Regulatory Submissions
- San Diego
- American
- Defect Tracking
- Timelines
- Rt Pcr
- Product Development
- Class 1
- Organizational Structure
- Process Improvement
- Legal Matters
- Business Analysis
- Guidance
- Medical Device Directive
- Debate
- Japan
- Coordinated
- Related Matters
- ISO 9001
- Track Record of Success
- Diagnose
- Molecular Pathology
- Portland
- Hsv
- Research
- Healthcare Compliance
- Executive Management
- Patient
- Implants
- Net
- NDA
- Strategies
- Project Initiation
- IEC 62304
- Life Sciences
- Cervical
- Testing
- Vancouver
- Design
- Management
- Translation
- Luminex
- Bone
- Combination Products
- Spinal Implants
- Risk Management
- Molecular
- Tissue
- EKG
- Quest Vworkspace
- Distribution
- Radiation
- Strategy
- Canada
- CLIA
- Meetings
- Mentoring
- Key Opinion Leaders
- Healthcare
- Ivdd
- Staff Development
- Government
- Rabqsa
- Instrumentation
- Labelling
- Innovative Technologies
- System Monitoring
- Advancement
- PMA
- History
- Employee Training
- Multi Site
- Legal
- CE marking
- Budgets
- Certified Lead Auditor
- Marketing Strategy
- System
- u.s. Food and Drug Administration
Randy Vader Summary
- Randy Vader, based in United States, is currently a Senior Vice President, Regulatory and Quality Affairs at FUJIFILM Healthcare Americas Corporation. Randy Vader brings experience from previous roles at FDA Compliance Group, Caris Life Sciences, Predictive Biosciences and Orthofix. Randy Vader holds a Bachelor of Science - BS @ San Diego State University. With a robust skill set that includes 21 CFR Part 11, Biochemistry, Biomedical Engineering, Biopharmaceuticals, Biotechnology and more. Randy Vader has 2 emails and 1 mobile phone numbers on RocketReach.
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