【Regulatory research】Regularly conduct regulatory research, evaluate the feasibility of international registration of customer products, determine product classification, registration path, etc.
【Pre-sales support】Assist business consultant to answer customer's pre-sales technical questions.
【International registration project planning】Formulate project strategy and plan according to the cooperation contract, and control the delivery of key nodes.
【International registration project delivery】Responsible for the international market declaration, access and regulatory registration of medical devices, including the collection, review, modification and reissue of relevant materials, and follow up on international certification matters.
【Process and knowledge precipitation】Assist in project process optimization, template building, knowledge extraction, training and other related enabling work.
1. Bachelor’s degree or above in Biological Science, Biotechnology, Medical Devices, Clinical Medicine, Mechanical Manufacturing or related fields;
2. CET-6 or above; candidates who can use English as a working language are preferred;
3. Familiar with quality system standards such as ISO13485, MDSAP, BGMP;
4. Experience in international registration projects, with experience in editing technical documents and registration documents is preferred;
5. Good communication skills, learning ability, service awareness and team spirit.
Email:hrbp@wiselinkchina.com