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Haiyan Wei Location
Irvine, CA, US
Haiyan Wei Work
Principal Regulatory Affairs Specialist @ (July 2023 - Present)
QA and RA Manager @ (January 2023 - July 2023)
Senior Regulatory Affairs Specialist @ (August 2018 - January 2023)
Regulatory Affairs Leader @ (August 2017 - August 2018)
Product Quality Leader @ (January 2014 - July 2017)
Product Surveillance Lead Engineer @ (April 2011 - January 2014)
Software Engineer (consultant) @ (January 2007 - March 2011)
Software Developer @ (May 2000 - August 2001)
Haiyan Wei Education
Rochester Institute of Technology
MS (Computer/Information Technology Administration and Management)
天津大学
BS (Industrial Engineering)
Haiyan Wei Skills
QSR
CE marking
510(k)
Six Sigma
Medical Devices
Cross-functional Team Leadership
Biomedical Engineering
Quality System
FDA
DMAIC
R&D
Quality Assurance
CAPA
Root Cause Analysis
Product Development
Testing
Medical Imaging
Process Improvement
Lean Manufacturing
Product Management
Design Control
Validation
Healthcare
Regulatory Affairs
Internal Audit
External Audit
Software Development
Product Surveillance
ISO 13485
Quality Auditing
Quality Management
Project Management
Leadership
Continuous Improvement
Regulatory Submissions
Regulatory Requirements
Regulatory Analysis
Global Regulatory Compliance
Regulatory Guidelines
Regulatory Reporting
Change Management
Risk Management
Complaint Investigations
Product Quality
GMP
Engineering
Microsoft Office
Requirements Analysis
IEC
Data Analysis
Technical Research
Cross Functional Team Leadership
Research
Haiyan Wei Summary
Haiyan Wei, based in Irvine, CA, US, is currently a Principal Regulatory Affairs Specialist at Glidewell Dental. Haiyan Wei brings experience from previous roles at CEDAR SINAI MEDICAL CENTER, Kerr Corporation and GE Healthcare. Haiyan Wei holds a MS in Computer/Information Technology Administration and Management @ Rochester Institute of Technology. With a robust skill set that includes QSR, CE marking, 510(k), Six Sigma, Medical Devices and more. Haiyan Wei has 2 emails and 1 mobile phone numbers on RocketReach.
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