Regulatory Officer
Job Responsibilities
- Responsible for the CE certification, FDA registration of the company's products, as well as the preparation and declaration of medical device product registration processes and product registration materials in other countries
- Responsible for cooperating with domestic and foreign agencies to complete overseas registration tasks
- Responsible for arranging some tests, data collection and sorting related to overseas registration, and ensuring that the registration information is complete and accurate
- Assist in the overall process control of product international registration and internal and external communication on related matters, and track the registration progress
- Responsible for the collection of relevant international standards, laws and regulations
- Assist in the preparation of quality management system documents.
Job Requirements
- Bachelor degree or above,
- Understand the requirements of medical device quality management system, and be familiar with relevant laws and regulations on medical devices such as the European Union and the United States,
- More than three years of registration experience, with practical experience in international registration of FDA, CE medical device products
- Strong writing skills and data organization skills, proficient in using office software.
- Have good communication and coordination skills.