2002 -
2008 Lead Director, Quality and Regulatory Affairs @ PHILIPS Healthcare
Randy Vader Education
San Diego State University
Bachelor of Science - BS
Randy Vader Skills
Medical Devices
Clinical Research
EMEA
Biotechnology
Regulatory Affairs
Quality System
Clinical Trials
Cancer
Lifesciences
ISO 13485
Infectious Diseases
FDA
Design Control
Cross-functional Team Leadership
CAPA
European Union
Oncology
Molecular Biology
Biochemistry
GMP
Pharmaceutical Industry
Hardware Diagnostics
Product Launch
R&D
Commercialization
Hospitals
Clinical Development
Market Development
Capital Equipment
Cardiology
Orthopedic
Validation
Global Marketing
Biomedical Engineering
Medical Diagnostics
Quality Control
Quality Assurance
Immunology
Technology Transfer
Biopharmaceuticals
In Vitro
Medicine
Genomics
Microbiology
IVD
GLP
Laboratory
21 CFR Part 11
Sop
V&V
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 Medical Devices, Clinical Research, EMEA, Biotechnology, Regulatory Affairs and more. Randy Vader has 3 emails and 1 mobile phone numbers on RocketReach.
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