Medical Device Auditor (IVD Field) / 医疗器械审核员(体外诊断领域)-北京-02426
This position is responsible for conducting Medical Health Services audit.
1.Perform In Vitro Diagnostic medical device audit according to standard requirements, regulatory requirements, internal requirements;
2.Perform evaluations of regulatory submissions including: Technical File Review (EU IVDD98/79EC Directives);
3.Provide project management for customers. It consists coordinating multiple projects, coordinating audit team and answer client questions;
4.Support sales and marketing of IVD filed in technical issues.
5.Perform other duties assigned by Deputy Manager / Department Manager.
1.Bachelor degree or above, Master degree is preferred ,in a science related field(Immunology, Biotechnology, biology, microbiology, Clinical Laboratory);
2.Minimum 4 years working experience in the fields of IVD medical device; e.g: Product Designer/Product Development Scientist/Project Manager/Microbiologist;
3.Minimum 2 years working experience in quality system management;
4.Good communication and interpersonal skills;
5.Can work independently and efficiently; can work under pressure;
6.Good computer skill;
7.Good command of English;
8.Physical condition allows normal working, stable outputs and business trip as required.