Qualifications :
- degree or above in a relevant discipline required
- years of industrial experience in IVD or medical device FDA registration
- in Chinese preferred
Tasks :
- and support new product 510k Submissions
- and support International Device Licensing and Registrations
- product development teams with new product submission requirements
- guidance on worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed
- and support the implementation of clinical research projects
- and support clinical sites management through all phases of the clinical trial
- to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled
- that documentation from clinical trial sites meets FDA / GCP / GDP requirements
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