Regulatory Compliance Analyst

2 months ago

Shanghai, Shanghai, China Thermo Fisher Scientific Full time

Position Overview:

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

Key Responsibilities:

  • Design and develop Chinese labels for non-medical products, ensuring that all information is precise and adheres to regulations.
  • Engage with manufacturing facilities to obtain English labeling data and relevant information.
  • Work closely with commercial teams to compile necessary label details.
  • Perform thorough data reviews to confirm accuracy and compliance with established standards.
  • Create and assess Chinese labeling templates, ensuring they are ready for non-medical device products.
  • Establish and manage a comprehensive dashboard and database for information pertinent to Chinese labeling.
  • Initiate notifications for changes when updates to labels or Instructions for Use (IFUs) are received from manufacturing sites.
  • Proactively communicate with sites to guarantee timely updates on Chinese labeling requirements.
  • Provide training to international plants regarding labeling regulations and compliance.
  • Develop and implement labeling processes in collaboration with various sites.
  • Take responsibility for corrective actions associated with Chinese labeling discrepancies.
  • Interpret and apply relevant regulations, including quality laws and national standards, to determine the requirements for Chinese labels for non-medical devices.
  • Perform additional tasks related to post-market product compliance as necessary.

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 mindset towards achieving results.
  • Excellent problem-solving skills, with the ability to identify issues and propose effective solutions.
  • Fluency in both spoken and written English.

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