Profile Details

Create Project

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USD 120 /hr

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Hire Dr. Juliana D.

Hong Kong

USD 120 /hr

China Regulatory Consultant for Medical Device

Profile Summary

Team manager for RA and Quality, Regulatory Affairs: CFDA Registration experiences in Medical device field,(imported Class 3 MD includes Defibrillators/Monitors/Ventilators/Ultrasound diagnostics/Catheters etc.) EU MDD Registration, for China-made Class 3 medical devices. APAC Countries MD registration (Korea, Singapore, Malaysia etc.). Solid knowledge and insights on CFDA/EU regulations, professional engagement with CFDA reviewers/test centers/Notified Bodies. Panel meeting experience with regulatory authority Quality Assurance: Lead factory quality team for QC and QA; Set-up brand new company's Quality system, and obtained initial ISO13485 within 6 month; Successful record of ISO13485 audit and China CFDA GMP audit; Clinical Study: Manage CRO to conduct clinical study in China for class 3 medical devices, regulatory input and review for clinical protocal

Subject Matter Expertise

• ★ Medical Device Regulatory Consulting
• ★ European Medical Device Regulation (MDR)
• ★ Regulatory Affairs

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Feasibility Study

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Material Sourcing

Work Experience

QA/RA Manager

ZOLL Medical

January 2014 - January 2018

RA Lead

GE Healthcare

January 2009 - January 2014

Education

MBA

University of International Business and Economics

January 2021 - Present

Bachelor's degree

Beijing University of Chemical Technology

January 2006 - January 2010

Certifications

• Certification details not provided.