Catherine Chen Email & Phone Number
SPM Franchise RA lead, EU MDR @ Smith & Nephew, Inc.
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Catherine Chen Location
- Andover, MA, US
Catherine Chen Work
- 2018 -now SPM Franchise RA lead, EU MDR @
- 2010 -now Senior Regulatory Affairs Specialist @
- 2009 -2010 Sr. QA Compliance Specialist @ Genzyme Corporation
- 2007 -2008 Regulatory Compliance Specialist II @
- 2004 -2006 QA Manager @
- 2001 -2004 QA Compliance Specialist @ Beijing Novartis Pharma Ltd.
- 1999 -2001 QC Analyst @ Hong Kong Wanji Groups Shenzhen Wanji Pharmaceutical Co., Ltd.
Catherine Chen Education
- Northeastern University 2009
- Shenyang Pharmaceutical University
Catherine Chen Skills
- FDA
- Regulatory Affairs
- Regulatory Submissions
- ISO 13485
- Quality Assurance
- CAPA
- Medical Devices
- V
- Regulatory Requirements
- ISO 14971
- Design Control
- GMP
- Validation
- Biotechnology
- U.S. Food and Drug Administration (FDA)
- V&V
- Quality System
- SOP
- Customer Service
- Research
- Management
- Agile Methodologies
- u.s. Food and Drug Administration Fda
- u.s. Food and Drug Administration
Catherine Chen Summary
- Catherine Chen, based in Andover, MA, US, is currently a SPM Franchise RA lead, EU MDR at Smith & Nephew, Inc.. Catherine Chen brings experience from previous roles at Smith & Nephew Inc., Genzyme Corporation and Alpharma Inc.. Catherine Chen holds a Northeastern University. With a robust skill set that includes FDA, Regulatory Affairs, Regulatory Submissions, ISO 13485, Quality Assurance and more. Catherine Chen has 2 emails on RocketReach.
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