Regulatory Affairs & QA Manager
深圳密易施贸易有限公司ShenzhenUpdate time: September 10,2019
Job Description

  • The China subsidiary of a global market leader, an Israeli innovative dental company is now recruiting a Regulatory Affairs Coordinator.


Responsibilities and duties:

  • Thorough understanding of the Chinese FDA registration requirements
  • Communicating the requirements in a clear manner to the HQ Regulation department as well as other departments
  • Hold meetings with the CFDA reviewers when required
  • Actively seek solutions for technical issues arised during the registration process
  • Prepare, write, edit & translate technical and clinical documents
  • Perform routine QC and QA activities as required by the CDFA
  • Maintaining the supervising the company internal working procedures to be aligned with the Chinese GDP


Key Requirements:

  • Academic degree in medical/biological/technical field
  • At least 3 year experience in medical registration- class 3
  • Experience in dental – advantage
  • Experience in dental implants- great advantage
  • Good technical understanding & skills
  • Able to look through the smallest details
  • English – high writing skills & good spoken skills
  • Willing to travel domestically and overseas frequently


  • What we offer:
  • Friendly and warm working environment
  • Being a part of an innovative company
  • Competitive salary & annual benefits



职能类别:医疗器械注册

关键字:注册法规医疗


上班地址:深圳市福田区沙头街道天安车公庙工业区天经大厦

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