Scott Volk
PetWellClinic® Franchise Owner; Director, Global Clinical Compliance at Edwards Lifesciences
- Role
- Director, Global Clinical Compliance at Edwards Lifesciences
- Location
- Orange County, CA, US
- LinkedIn followers
- 500 followers
About Scott Volk
Clinical Research and Quality Assurance professional experienced in providing operational…
Experience
Director, Global Clinical Compliance
Jan 2020 — Present · Irvine, CA, US
Responsible for leading the Global Clinical Compliance function in the ongoing support of PMA and post-market commitment studies in the area of Transcatheter Heart Valves (THV). Tasked to develop and define the vision and compliance support structure leading to real-time inspection readiness of the Clinical Affairs organization focused on proactively building quality into all phases of the clinical development process.
Skills
- Clinical Trials
- Regulatory Affairs
- Clinical Operations
- Clinical Development
- Gastroenterology
- Infectious Diseases
- Ich-Gcp
- Clinical Monitoring
- CRO
- Medical Devices
- Clinical Research
- Pharmaceutical Industry
- Sop
- Fda
- Good Clinical Practice (Gcp)
- Gcp
- Clinical Data Management
- Edc
- Therapeutic Areas
- Ctms
- Regulatory Submissions
- Oncology
- Protocol
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