Compliance Specialist II

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

About Thermo Fisher Scientific Inc.

Thermo Fisher Scientific Inc. is a world-class company dedicated to enabling our customers to make the world healthier, cleaner, and safer. As a global leader in the field of information technology, we are committed to driving technological innovation and supporting patients in need. With a team of over 100,000 colleagues, we value diversity and believe that diverse experiences, backgrounds, and perspectives contribute to our success.

Compliance Specialist II - Job Responsibilities:

• Responsible for the design of Chinese labels for products, ensuring flawless and accurate information.
• Connect with manufacturing sites to collect English label or label information.
• Collaborate with commercial colleagues to gather label information.
• Conduct data review to ensure accuracy and compliance.
• Prepare Chinese labeling templates and review and release them for products.
• Build and maintain a dashboard and database of information used for Chinese labeling.
• Work closely with manufacturing sites on process creation, label change control management and regulation sense refresh.
• Take ownership of corrective actions related to Chinese labels.
• Interpret relevant regulations such as medical devices labeling related, quality laws, industrial standards, and national standards to determine Chinese label requirements for non-medical devices.
• Other post-market product compliance relevant tasks.

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• 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.