- Degree holder in medical Engineering
- 3-5 year in Regulatory in medical device in Trading or Factory
- Good knowledge in ISO 13485, ISO9001, 510K, CE, CMDCAS, CFDA legislation.
- Proficient of English and Mandarin
- Handle regulatory affairs, such as product license registration/renewal, coordinating customers/internal audits, preparing of ISO documentations and etc.
- Comply with ISO 13485.
- Conduct training for staff to fulfill the regulatory requirements.
- Good knowledge in ISO 13485, ISO9001, 510K, CE, CMDCAS/MDSAP, CFDA / NMPA legislation.
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