Careers at ThermoFisher Scientific

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Job ID :
Location :
China - Shanghai
Job Description
  • Responsible for post market product compliance, include but not limited to the medical device products.
  • Be able to collect, monitor analyze and interpret product relevant regulations professionally
  • Be able to collect, monitor, analyze and interpret product relevant industrial standards, national standards.
  • Minimum Qualifications:

    • Bachelor degree.

    • Minimum of Five (5) years’ experience in the Medical Device industry or associated manufacturing or service industries.

    • Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to China GSP, 21 CFR 820, and ISO 13485.

    • Thorough understanding of quality science, knowledge of continuous improvement methodologies, knowledge of quality systems

    • Excellent communication skills

    • Problem identification, analysis, providing solutions

    • Fluency in English both on speaking and writing.

  • Responsible for preparing the Chinese labeling templates, review and approve Chinese labeling for the import products
  • Host the post market audits
  • Maintain the medical device distribution licenses.
  • Maintain the GSP master data and responsible for the initial approval of suppliers/customers in GSP
  • Other post-market product compliance relevant tasks

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