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Regulatory Compliance Analyst

2 months ago

Shanghai, Shanghai, China Thermo Fisher Scientific Full time

Position Overview:

The Compliance Specialist will play a critical role in ensuring that all labeling for non-medical device products meets regulatory standards and is accurately represented in Chinese. This position involves a variety of responsibilities aimed at maintaining compliance and enhancing the quality of product information.

Key Responsibilities:

  • Design and oversee the creation of Chinese labels for non-medical products, ensuring that all information is precise and compliant.
  • Collaborate with manufacturing facilities to gather necessary English label data.
  • Work closely with commercial teams to compile and verify label information.
  • Conduct thorough data reviews to ensure accuracy and adherence to compliance standards.
  • Prepare and evaluate Chinese labeling templates for non-medical device products, ensuring they meet all necessary requirements.
  • Develop and maintain a comprehensive dashboard and database for Chinese labeling information.
  • Initiate change notifications in response to updates received from manufacturing regarding labels or Instructions for Use (IFUs).
  • Engage directly with sites to guarantee timely updates on Chinese labeling.
  • Provide training to international plants on relevant labeling regulations.
  • Establish and refine labeling processes in collaboration with manufacturing sites.
  • Take responsibility for corrective actions related to Chinese labeling discrepancies.
  • Interpret and apply relevant regulations, including quality laws and industrial standards, to determine the requirements for Chinese labels for non-medical devices.
  • Perform additional post-market product compliance tasks as needed.

Minimum Qualifications:

  • Bachelor's degree in a relevant field or equivalent professional experience.
  • Demonstrated experience in product labeling.
  • In-depth knowledge of quality science and continuous improvement practices.
  • Strong communication skills and a proactive approach to achieving compliance objectives.
  • Excellent problem-solving skills, with the ability to identify issues and provide effective solutions.
  • Fluency in both spoken and written English.