Regulatory Compliance Analyst
2 months ago
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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