◆ Business license
• Business license application,maintenance of documents and records,sample
management, Corresponding on-site inspection
• Corresponding internal inspection
◆ Audit
• Corresponding product sampling inspection by NMPA
• Factory quality system assessment, and inspection by NMPA
• Possible product arrival to customs inspection, support supply chain Dep
◆ Risk Analysis Report (Annual)
• Planning the schedule of the risk analysis report for relevant products , records,
submission to NMPA on time.
◆ Adverse event handling
• Closely communicate with Sales rep to collect the products and detail information,
report to HQ on time, solution
• Submit the Adverse event analyses report according to NMPA special required
◆ Document control
• Related sop establishment
• File cabinet management
◆ Testing samples management
• Testing samples management, support the supply chain dep, records
◆ Upskilling
• Actively participate in seminars and related training by NMPA, Medical device
association, etc.
◆ Building the good relationship
• Building the good relationship with NMPA, Testing center and related KOL

1、本科以上学历，医药、食品工程或生物医药等相关专业出身，英语或日语能够作为工作语言，
读写熟练，口语流利；
2、具有 3~5 年医疗器械、医药或者化妆品行业质量管理工作经验（具备医疗器械行业经验者优
先）, 包括经营许可证相关的全盘管理经验（制定・修订 SOP、记录管理、内部监察、向当
局的申请、监察对应业务等)
3、熟悉 NMPA（原 CFDA）法律法规以及质量管理工作流程；
4、综合素质高，积极进取，具有优秀的沟通协调能力；
5、能够熟练运用 word、ppt、excel 等 office 办公软件；
6、具备良好的职业素养，为人品行端正，诚实守信，遵守法律法规及公司内部管理规定。