Asia Pacific Regulatory Affairs and Quality Assurance Specialist

7 days ago


Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

The Asia Pacific Regulatory Affairs and Quality Assurance Specialist will play a critical role in ensuring that our medical devices comply with regional regulations and standards. The successful candidate will be responsible for gathering and preparing materials to enable Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc. decision-making process.

This role involves collating and preparing all materials, reports, and follow-up with Regulatory Agencies regarding recall activity. May prepare documentation and reports after interpreting Asia Pacific countries regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.

Excellent verbal and written English and Chinese (Mandarin) communication skills, strong attention to detail, and excellent organizational skills are essential.



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