職位描述
Position Summary
?Be in charge of RA team management
?Be in charge of imported medical devices registration in CFDA.
?Support to other functions on regulation affair issues.
Key Accountabilities:
?Be responsible for the import medical device registration in CFDA.
?Organize and implement registration tests and clinical trials.
?Preparing product registering submissions, tracking the process and obtain registration approval certificate as early as possible based on Registration Plan.
?Necessary registration document translation and check.
?Cooperated with central RA to get necessary information and data.
?File and maintain registration documents.
?RA team work management and guide
?Support to other functions on RA issues.
Skills & Capabilities:
?Proficient in office software, especially in Word, Excel and PowerPoint.
?Good communication skills
Min Knowledge & Experience required for the position:
?Medical Laboratory Science /Medical Technologist, Bachelor degree
?Fluent English
?Minimum 5 years working experience in registering, know the register process and policy.
企業介紹
50多年來,Werfen在體外診斷解決方案方面不斷研發創新來提高效率并加強對病人的呵護。針對這個目標的不懈努力使我們在血凝、急癥診斷和自身免疫這些體外診斷專業領域一直居于全球領導地位。 在這些臨床領域的專注和專業,以及以客戶為主的研發模式是我們成功的關鍵。通過與我們的制造公司:美國實驗儀器公司、Inova Diagnostics和Biokit的密切合作,我們分享最佳方案,優化效率,一起更快更好地實現重大突破。
我們致力于為醫院和臨床實驗室開拓創新的未來,不斷提升質量；并且,永遠不會忘記每一個樣本的背后都有一個病人在等待幫助。
