Job Responsibilities:

1. Develop a registration plan, advance and manage the registration progress according to the plan;

2. Interpretation and implementation of international regulations related to medical devices;

3. Manage communication with overseas agents and regulatory authorities;

4. Handling emergencies and other tasks assigned by superiors.

Job Requirements:

1. Bachelor's degree or above, with a preference for majors in biomedicine, chemical materials, foreign languages, or related fields;

2. English proficiency level 6 or above, capable of independent oral communication; Having good interpersonal communication and coordination skills, team management experience is preferred;

3. More than 3 years of overseas registration experience in medical devices, independently completing complete registration projects; Priority will be given to successful FDA 510 (k) registration cases in the United States;

4. Familiar with overseas medical device regulations and registration processes, such as Europe, America, Latin America, Southeast Asia, etc;

5. Has strong resilience, learning ability, and sense of responsibility.