招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
1. Principal Duties and Responsibilities
- Product registration related including new and renewal
? Handling registration processes for MIP, including
？ Document requirement
？ Dossier preparation
？ Submit to CFDA
？ Follow up evaluation procedure
？ Sample ordering, type testing
？ Solve various problems in whole process
? Ensure to obtain the regulatory permits on time, in support of the organization’s business requirements
? Having a good and consistent communication with local marketing and known well the business plan especially product launch plan
? Figuring out a rational working registration plan
? Keeping all medical device relevant regulations in mind and having the own opinion on revision when necessary
? To coordinate the post market surveillance and recall with the written explanation if happening
? Working for product related copy review with the regulatory opinion
? Support Chinese IFU and labeling for product related
- Being proactive to participate the industrial activities to contribute the constructive suggestion
- Paying attention to the market information such as the competitors’ with the analysis
- Being involving into team working such as department meeting logistic arrangement
- Bearing part of new employee orientation training
- Maintain & input database like RA database, RTL…
- Provide monthly report & analysis including latest registration status & post market surveillance.
- Medical or related education background and knowledge
- 3-5 years Medical Device registration experience
- Good communication skill
- Better English and Chinese in writing and oral
- Well computer operating
- Good time management
求职提醒：求职过程请勿缴纳费用，谨防诈骗！若信息不实请举报。
