苏州招聘

1. Principal Duties and Responsibilities

- Product registration related including new and renewal

? Handling registration processes for Mitek, 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.

2. Requirements

- 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

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