Scott Goldstein
Sr. Global Director, Quality Assurance & Regulatory Affairs at Apyx Medical
- Role
- Sr Global Director - Quality Assurance & Regulatory Affairs at Apyx Medical
- Location
- Tampa, FL, US
- LinkedIn followers
- 500 followers
Experience
Sr Global Director - Quality Assurance & Regulatory Affairs
Oct 2025 — Present · Clearwater, FL, US
Responsible for oversight of all Quality Assurance and Regulatory Affairs activities and associated personnel at all Apyx Medical sites (Clearwater, FL and Sofia, Bulgaria).Develop and execute regulatory strategies to support the business, including oversight of worldwide regulatory submissions and registrations, including 510k submissions, foreign government submissions, registrations and renewals.Oversee Post-Market functions (complaints, adverse event reporting, field actions, post market surveillance).Develop, deploy, and execute quality policies, objectives and plans that align and support the corporate strategic business goals.Oversee the Quality Assurance functions (Change Management, Document and Record Control, NCRs, CAPAs, Validation, Audits, Supplier Management, and Training).Ensure the Quality Management System is compliant with FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR, NMPA, KGMP, and other regulatory requirements as applicable.
Education
University of Michigan College of Engineering
Master of Science (M.S.), Biomedical Engineering
2012 — 2013
University of Michigan
Bachelor of Science (B.S.), Cellular and Molecular Biology/Biomedical Engineering
2008 — 2012
Skills
- Design Control
- Biologics
- Validation
- Research
- Lean Manufacturing
- Matlab
- Medical Devices
- Capa
- Manufacturing
- Auditing
- Fda Gmp
- Biotechnology
- Biomedical Engineering
- Data Analysis
- Iso 11137
- Sql
- Quality System
- Iso 13485
- Quality Assurance
- Troubleshooting
- R&D
- Fda
- Microsoft Excel
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