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Work Schedule

Standard (Mon-Fri)

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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 non-MD 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 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.

• Independently connect with sites to ensure timely updates on Chinese labeling.

• 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 such as quality laws, industrial standards, and national standards to determine Chinese label requirements for non-medical devices.

• Other post-market product compliance relevant tasks.

Minimum Qualifications:

• 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.

Apply Today!

Join us at Thermo Fisher Scientific Inc. and be part of our ambitious team to start your story with us. We appreciate and value diverse experiences, backgrounds, and perspectives.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.