Niki Spaniel Email & Phone Number

Niki Spaniel Skills

• Auditing
• Good Clinical Practice (GCP)
• Global Regulatory Compliance
• Post Market Surveillance
• PMCF Plans/Reports
• Technical Leadership
• Organizational Leadership
• Change Management
• Clinical Trials,
• Regulatory Compliance
• Regulatory and Clinical Strategy
• Resource Allocation
• Team Leadership
• Regulatory Strategy
• Leadership
• Conflict Resolution
• Written Communication
• Manager and Mentor
• Clinical Strategy
• PMCF Retrospective Studies
• Clinical Development
• Communication
• Project Teams
• Clinical Study Design
• Post-market Clinical Follow-up Planning and Strategy
• Global Regulatory Strategy
• Clinical Evidence Assessment
• Regulatory Intelligence
• FDA
• ISO 13485
• Quality System
• CAPA
• Product Development
• Quality Assurance
• V&V
• Internal Audit
• Medical Devices
• Design Control
• Regulatory Requirements
• Medical Device Directive
• ISO 14971
• 21 CFR
• CE marking
• FDA GMP
• Clinical Trials
• IRB Submissions
• HIPAA
• CLIA
• Document Control
• Corrective Actions
• Management Review
• CMDCAS
• Quality Auditing
• Quality Control
• Regulatory Affairs
• Regulatory Submissions
• GMP
• Supplier Quality
• Software Documentation
• Quality Management
• Root Cause Analysis
• Document Management
• Verification and Validation (V
• U.S. Food and Drug Administration (FDA)