Alison Sathe Email & Phone Number
Senior Vice President - Quality Intelligence @ FDAzilla
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Alison Sathe Location
- Cincinnati, OH, US
Alison Sathe Work
- Senior Vice President - Quality Intelligence @ (January 2026 - Present)
- Senior Vice President, Data Strategy and Analytics @ (June 2024 - Present)
- Senior Vice President, MedTech @ (April 2022 - June 2024)
- Founder @ (January 2019 - June 2024)
- Founder @ (January 2014 - April 2023)
- Director of Regulatory and Clinical Affairs @ (September 2014 - September 2015)
- Director of Regulatory and Clinical Affiars @ (August 2010 - September 2014)
- Regulatory and Clinical Affairs @ AtriCure, Inc. (January 2004 - January 2010)
Alison Sathe Education
- University of Cincinnati
Bachelor of Science (B.S.) (Biomedical/Medical Engineering)
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
Alison Sathe Summary
- Alison Sathe, based in Cincinnati, OH, US, is currently a Senior Vice President - Quality Intelligence at Redica Systems. Alison Sathe brings experience from previous roles at Redica Systems, ClearMark and Regulatory Mark. Alison Sathe holds a Bachelor of Science (B.S.) in Biomedical/Medical Engineering @ University of Cincinnati. With a robust skill set that includes Artificial Intelligence (AI), Software, Quality Management System, Regulatory Intelligence, ISO 13485 and more. Alison Sathe has 2 emails and 2 mobile phone numbers on RocketReach.
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Alison Sathe
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