Shuzhi Zhang

Shuzhi Zhang Email and Phone Number

Regulatory Affairs Manager @ Genabio Diagnostics
Shuzhi Zhang's Location
Framingham, Massachusetts, United States, United States
Shuzhi Zhang's Contact Details

Shuzhi Zhang personal email

About Shuzhi Zhang

Shuzhi Zhang is a Regulatory Affairs Manager at Genabio Diagnostics. He possess expertise in regulatory affairs, clinical trials, gcp, pharmaceutical industry, cro and 23 more skills. He is proficient in English.

Shuzhi Zhang's Current Company Details
Genabio Diagnostics

Genabio Diagnostics

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Regulatory Affairs Manager
Shuzhi Zhang Work Experience Details
  • Genabio Diagnostics
    Regulatory Affairs Manager
    Genabio Diagnostics Aug 2023 - Present
    Bedford, Massachusetts, Us
  • Syneron Candela
    Sr. Regulatory Affairs Specialist
    Syneron Candela Apr 2022 - Jul 2023
    Wayland, Massachusetts, Us
  • Syneron Candela
    Regulatory Affairs Specialist
    Syneron Candela Nov 2018 - Mar 2022
    Wayland, Massachusetts, Us
  • Cro Group Inc.
    Regulatory Affairs Specialist
    Cro Group Inc. Nov 2016 - Nov 2018
  • Cro Group Inc.
    Regulatory Affairs Junior Associate
    Cro Group Inc. Jul 2012 - Oct 2016
    • Maintaine the update of regulations and guidance of regulatory affairs in U.S., EU, Canada, etc.• Provide regulatory opinions and relevant references to internal meetings, request and concerns, design review meeting, etc.• Prepared 510(k) submission for the devices • Conduct the 510(k) analysis, and participate the problem-solving discussion • Provide regulatory support to marketing/promotion materials• Interpret the ISO 13485, 21 CFR 820, MEDDEV and applied the regulations to the submission preparation• Assist Field Service department reviewing customer feedback, RMA, complaints and offering trend analysis and report • Assist the Technical File Checklist and Strategy Preparation
  • Northeastern University
    Graduate Student Of Regulatory Affairs
    Northeastern University Sep 2010 - Mar 2012
    Boston, Ma, Us
    M.S. of Regulatory Affairs from Northeastern University;International Student Scholarship
  • Zhujiang Hospital Of Southern Medical University
    Nursing Assistant
    Zhujiang Hospital Of Southern Medical University Jul 2008 - Jun 2009
    * Provided administrative support to supervisor for documents, records, and schedule maintenance* Lead group studying of update medical news and nursing methods* Coordinated registered nurses and other colleges with routine medicine administration

Shuzhi Zhang Skills

Regulatory Affairs Clinical Trials Gcp Pharmaceutical Industry Cro Clinical Research Life Sciences Iso 13485 Microsoft Office Healthcare Strategy Quality Assurance Fda Biotechnology Medical Devices Regulatory Submissions Management Irb Pharmaceuticals Ctms Clinical Monitoring 21 Cfr 820 Cgmp Software Validation U.s. Food And Drug Administration Gmp Iso 14971 Risk Management Iso 13485 Quality Management System For Medical Device Regulatory Requirements

Shuzhi Zhang Education Details

  • Northeastern University
    Northeastern University
    Biologics And Medical Devices
  • Southern Medical University
    Southern Medical University
    Nursing

Frequently Asked Questions about Shuzhi Zhang

What company does Shuzhi Zhang work for?

Shuzhi Zhang works for Genabio Diagnostics

What is Shuzhi Zhang's role at the current company?

Shuzhi Zhang's current role is Regulatory Affairs Manager.

What is Shuzhi Zhang's email address?

Shuzhi Zhang's email address is sh****@****ela.com

What schools did Shuzhi Zhang attend?

Shuzhi Zhang attended Northeastern University, Southern Medical University.

What skills is Shuzhi Zhang known for?

Shuzhi Zhang has skills like Regulatory Affairs, Clinical Trials, Gcp, Pharmaceutical Industry, Cro, Clinical Research, Life Sciences, Iso 13485, Microsoft Office, Healthcare, Strategy, Quality Assurance.

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