Regulatory Compliance Analyst
2 months ago
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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