1. Develop, implement and manage the pre-marketing medical strategies of CE/FDA project, including communication with experts, protocol discussion and revision, training of CRA or MSL, and data analysis and summary, etc.
2. Be responsible for the medical-related analysis and communication with various parties (such as regulatory agencies, CRO companies and consulting companies) during the project.
3. Be responsible for the training of the product and operation. Lead the professional guidance and patient analysis, etc.
4. Regularly sort out the serious adverse events or unexpected adverse events occurred during the clinical trials. Track and collect the information about the adverse reactions of the devices,and discuss and analyze them with relevant colleagues for improvement.
5. Track the relevant medical information, update the product medical knowledge base and organize the relevant training.
6. Based on the medical and market planning of the product line, cooperate with the organization of academic conferences. Answer the product-related medical questions. Assist in the preparation and review of the promotional materials.
7. Other medical-related matters as assigned.
1. Clinical medicine or related majors. Master's degree or above, with relevant working background in cardiovascular field.
2. At least 5 years of relevant work experience (can be relaxed with a PhD or relevant project experience in CE/FDA).
3. Accept overseas business trips (mainly in Europe and the United States).
4. Strong communication and expression skills.
5. Good writing skills.
6. Fluent in English in listening, speaking, reading, and writing, which can be used as working language.
7. Preference will be given to those with overseas work/study experience, and those with work experience in Western European or American multinational enterprises.