Cecilia Silva
Director Regulatory Affairs at ResMed
- Role
- Director of Regulatory Affairs at Resmed
- Location
- San Diego, US
- LinkedIn followers
- 500 followers
Experience
Director of Regulatory Affairs
Sep 2024 — Present
Skills
- Quality System
- V&V
- Clinical Trials
- Ctms
- Regulatory Submissions
- Biomaterials
- Iso 14971
- Change Control
- Clinical Development
- Medical Devices
- Clinical Research
- Capa
- Quality Control
- Gmp
- Biomedical Engineering
- Design Control
- Gcp
- R&D
- Protocol
- 21 Cfr Part 11
- Biotechnology
- Product Launch
- Quality Auditing
- Iso 13485
- Regulatory Requirements
- Quality Assurance
- Validation
- U.s. Food and Drug Administration (Fda)
- Irb
- CRO
- Regulatory Affairs
- Lifesciences
- Orthopedic
- Pharmaceutical Industry
- Sop
- Fda
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