Regulatory Compliance Specialist

4 weeks ago

Shanghai, Shanghai, China Thermo Fisher Scientific Full time

Job Summary:

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Thermo Fisher Scientific. In this role, you will be responsible for ensuring the accuracy and compliance of Chinese labels for non-MD products.

Key Responsibilities:

  • Design and implement Chinese labeling templates for non-medical device products.
  • Collaborate with commercial colleagues to gather label information and ensure accuracy.
  • Conduct data review to ensure compliance with relevant regulations.
  • Prepare and release Chinese labeling templates for non-medical device products.
  • Build and maintain a dashboard and database of information used for Chinese labeling.
  • Initiate change notifications when updates on labels or IFUs are received from manufacturing sites.
  • Deliver training to overseas plants on labeling regulations.
  • Establish label processes with sites.
  • Take ownership of corrective actions related to Chinese labels.
  • Interpret relevant regulations to determine Chinese label requirements for non-medical devices.

Requirements:

  • Bachelor's degree in a related field or equivalent experience.
  • Proven track record of experience in labeling.
  • Extensive knowledge and understanding of quality science and continuous improvement methodologies.
  • Exceptional communication abilities and a proactive approach to achieving outcomes.
  • Strong problem identification, analysis, and solution-providing abilities.
  • Proficiency in both spoken and written English.

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