工作職責Responsibilities:
1、負責醫療器械國際市場準入和注冊工作；
To undertake the medical device registration works in International area；
2、負責相關區域的醫療器械法規的研究分析和導入、產品注冊資料的編寫、收集、遞交；
To undertake the analysis and implementation of related regulations and technical standards of medical devices; writing, collecting and submitting the registration dossier；
3、負責醫療器械注冊過程中與注冊顧問及相關監管機構的聯絡溝通；解決注冊問題，推進注冊進程、保證良好注冊結果；
To maintain active communication with consultants, and relating authorities; solving registration problems, pushing forward the registration process and guarantee a favorable registration result。

職位要求Job Requirements:
1、電子、自動化類理工科專業背景，生物醫學工程專業優先；
Major in electronics, automation engineering and biomedical engineering will be preferable；
2、有醫療行業法規注冊相關工作經驗優先（一類二類三類都可以）；
Working experience in medical device registration will be preferable；
3、具備良好的溝通合作的能力和團隊合作精神，抗壓能力強；
Excellent communication skills with team work spirit; ability to maintain good performance under pressure；
4、良好的英語讀寫能力；
Good communication skill includes English in reading/writing and oral。