Alison Sathe
- Role
- Senior Vice President, Medtech at Redica Systems
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Alison Sathe
Experienced Regulatory and Clinical Affairs consultant for medical technology with…
Experience
Senior Vice President, Medtech
Apr 2022 — Present
Redica Systems is a data and software company that provides regulatory and quality intelligence to FDA-regulated industries. The company serves 200+ pharmaceutical and medical device firms, helping them stay ahead of global regulatory changes, access extensive enforcement and inspection intelligence, monitor supplier risk, and improve team collaboration.
Skills
- Regulatory Analysis
- Regulatory Compliance
- Federal & State Regulatory Compliance
- Fda Gmp
- Capa
- Quality Auditing
- Regulatory Strategy Development
- Regulatory Requirements
- Global Regulatory Compliance
- Clinical Research
- Quality Systems
- Strategy
- Fda
- Quality System
- Verification and Validation (V&V)
- U.s. Food and Drug Administration (Fda)
- Validation
- 21 Cfr
- Iso Standards
- Clinical Trials
- Regulatory Audits
- Ce Marking
- Regulatory Guidelines
- Regulatory Filings
- Design Control
- Regulatory Documentation
- Biomedical Engineering
- V&V
- R&D
- Regulatory Submissions
- Iso
- Regulatory Risk
- Product Development
- Cross-Functional Team Leadership
- Iso 13485
- Iso 14971
- Regulatory Policy
- Biotechnology
- Quality Assurance
- Regulatory Affairs
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