Shuzhi Zhang
- Role
- Regulatory Affairs Manager at Genabio Diagnostics
- Location
- Framingham, MA, US
- LinkedIn followers
- 500 followers
Experience
Regulatory Affairs Manager
Aug 2023 — Present
Skills
- Regulatory Affairs
- Ctms
- Fda
- Gcp
- CRO
- Software Validation
- Clinical Research
- Medical Devices
- Management
- U.s. Food and Drug Administration (Fda)
- 21 Cfr 820 Cgmp
- Pharmaceuticals
- Life Sciences
- Regulatory Submissions
- Irb
- Clinical Trials
- Microsoft Office
- Gmp
- Clinical Monitoring
- Iso 13485 Quality Management System for Medical Device
- Iso 14971 Risk Management
- Strategy
- Healthcare
- Pharmaceutical Industry
- Biotechnology
- Iso 13485
- Quality Assurance
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