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Responsibilities:
1. Collect, compile and maintain regulatory files, such as CSDT, and ensure maintenance of registrations occurs including initial registration, re-registration and change of notification.
2. Build and manage regulatory affairs database, such as CSDT database, certificate database and etc.
3. Produce technical documents to support GDPMD regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
4. Stay abreast of changes in regulatory procedures and legislations, ensure enforcement of such changes and keep the management updated accordingly.
5. Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner.
6. Support external regulatory agency audits, providing regulatory input to minimize findings of non-compliance. Coordinate and assist in preparing response to regulatory authorities’ queries within stipulated timelines.
Requirements:
1. Major in electronics, automation engineering and biomedical engineering will be preferable；
2. Working experience in medical device registration will be preferable；
3. Excellent communication skills with team work spirit; ability to maintain good performance under pressure；
4. Good communication skill includes English in reading/writing and oral
