Alison Sathe Email & Phone Number

Alison Sathe Skills

• Artificial Intelligence (AI)
• Software
• Quality Management System
• Regulatory Intelligence
• ISO 13485
• Design Control
• Clinical Research
• R&D
• CAPA
• Quality System
• ISO 14971
• Regulatory Affairs
• Biomedical Engineering
• FDA
• V&V
• ISO
• 21 CFR
• Product Development
• Cross-functional Team Leadership
• Quality Systems
• ISO standards
• Training
• FDA GMP
• Quality Auditing
• Medical Devices
• CE marking
• Regulatory Submissions
• Regulatory Compliance
• Global Regulatory Compliance
• Verification and Validation (V&V)
• U.S. Food and Drug Administration (FDA)
• Regulatory Requirements
• Regulatory Reporting
• Clinical Trials
• Quality Assurance
• Biotechnology
• Validation
• Strategy
• Regulatory Documentation
• Regulatory Guidelines
• Regulatory Filings
• Regulatory Analysis
• Federal & State Regulatory Compliance
• Regulatory Policy
• Regulatory Audits
• Regulatory Risk
• Regulatory Strategy Development
• medical device development
• Start-ups
• Laser
• Federal and State Regulatory Compliance
• Cross Functional Team Leadership
• Startups
• Clinical Affairs
• Microsoft Office
• Management
• Medical Technology
• Pharmaceutical Industry
• Hospitals
• Start Ups
• Energy
• Project Management
• Cross Functional Team
• u.s. Food and Drug Administration Fda
• Verification and Validation V&V
• Leadership
• Global Regulatory
• u.s. Food and Drug Administration
• Verification and Validation