Fast and efficient registration for responsible products and contribute the time to market. Responsible for all regulatory issues from pre and post market, take the lead for RA key project.
Areas of Responsibilities:
1. Work together with BL RA for all registration activities include testing, documents preparation, submission and achieve product license target in fast and effective way;
2. Maintain or develop good working relationship and cooperation with relevant authorities like test labs, NIFDC,CMDE, SFDA and NMPA etc. to improve working efficiency;
3. Close communicate with external and internal partners, take proactive action to continuous optimize internal process and adapt registration strategy according to latest regulation;
4. Work with regulatory partner in BAs/BUs to achieve product licenses in such time period;
5. Manage and lead the RA team to achieve product license target in the most efficient pathways, coach and develop team members;
6. Take the lead for the key and critical registration project.
Education and Experience
1.Bachelor degree or above relevant in medical/ biological/engineering etc.
2. Above 5 years in regulatory affair, prefer for IVD
3.Good experience in medical device product registration, standardization
4.Good experience in working with foreign company
5.Fluent Chinese and English skills both in verbal and written.
6.Able to work under high pressure
Organization: Siemens Healthineers
Company: Siemens Healthineers Ltd.
Experience Level: Experienced Professional
Job Type: Full-time