Regulatory Compliance Analyst

2 months ago

Shanghai, Shanghai, China Thermo Fisher Scientific Full time

Position Overview:

The Compliance Specialist will play a crucial role in ensuring that all labeling for non-medical device products meets regulatory standards and is accurately represented in Chinese. This position requires a detail-oriented individual who can effectively collaborate with various teams and stakeholders.

Key Responsibilities:

  • Design and develop Chinese labels for non-medical products, ensuring all information is precise and compliant.
  • Engage with manufacturing facilities to obtain necessary English label data.
  • Work closely with commercial teams to compile and verify label information.
  • Perform thorough data reviews to maintain accuracy and adherence to compliance standards.
  • Create and assess Chinese labeling templates, ensuring they are ready for release.
  • Maintain a comprehensive dashboard and database for all Chinese labeling information.
  • Initiate change notifications in response to updates from manufacturing regarding labels or Instructions for Use (IFUs).
  • Proactively liaise with sites to guarantee timely updates on Chinese labeling.
  • Provide training to international plants on labeling regulations and compliance requirements.
  • Establish and refine labeling processes in collaboration with manufacturing sites.
  • Take responsibility for corrective actions associated with Chinese labeling discrepancies.
  • Interpret and apply relevant regulations, including quality laws and national standards, to determine labeling requirements.
  • Engage in additional post-market compliance tasks as necessary.

Minimum Qualifications:

  • Bachelor's degree in a relevant field or equivalent professional experience.
  • Demonstrated experience in product labeling and compliance.
  • In-depth knowledge of quality science and continuous improvement practices.
  • Strong communication skills with a proactive approach to problem-solving.
  • Excellent analytical abilities to identify and resolve issues effectively.
  • Fluency in both spoken and written English.

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