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.

50多年来,Werfen在体外诊断解决方案方面不断研发创新来提高效率并加强对病人的呵护。针对这个目标的不懈努力使我们在血凝、急症诊断和自身免疫这些体外诊断专业领域一直居于全球领导地位。 在这些临床领域的专注和专业,以及以客户为主的研发模式是我们成功的关键。通过与我们的制造公司:美国实验仪器公司、Inova Diagnostics和Biokit的密切合作,我们分享最佳方案,优化效率,一起更快更好地实现重大突破。
我们致力于为医院和临床实验室开拓创新的未来,不断提升质量；并且,永远不会忘记每一个样本的背后都有一个病人在等待帮助。