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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Shanghai, China
Job Description:
Key Responsibilities:
- Perform business intelligence analytics mainly utilizing MDRIM and Smartsheet data
- Establish and maintain data connections to facilitate periodic performance tracking
- Provide operation support and troubleshooting assistance for MDRIM systems
- Manage data operations, including downloading, organizing, and analyzing data to support regional RA project management and change control
- Support regional/local RA to enhance team efficiency by
- liaising between local RA teams and the stakeholders (IT, DataOps, RegOps)
- assist with administrative tasks
Qualifications:
- Experience with business intelligence tools such as Power BI, Smartsheet, and other relational databases
- Strong knowledge, experience, and skills related to MDRIM data operations
- Solid data management and analysis skills, with meticulous attention to data integrity
- Excellent communication and teamwork abilities
- Fundamental knowledge of the medical device regulatory process
- Enthusiasm for learning new concepts and adaptability to environmental changes
- Fluency in English
