1. Liaise with R&D to manage international market registration submissions, including drafting, organizing, reviewing, and submitting documentation;
2. Communicate proactively with regulatory authorities or review bodies to resolve issues arising during registration; monitor project timelines to ensure timely certification;
3. Identify applicable medical device standards and relevant guidelines; lead regulatory and standards training for R&D teams;
4. Participate in design and development processes, incorporate target market regulations and relevant standards requirements, and formulate product registration strategies;
5. Coordinate sample submissions and confirm various test reports (IEC, EMC, biocompatibility);
6. Organize and archive registration-related documentation;
7. Complete other tasks assigned by superiors.

1. Bachelor's degree or higher, preferably in biomedical engineering, electronics, or mechanical engineering;
2. Minimum 2 years of experience in active medical device registration, with prior success in FDA and CE registration submissions preferred;
3. Proficiency in English as a working language, with excellent reading and writing skills;
4. Strong sense of responsibility, excellent problem-solving abilities, and effective communication and coordination skills;
5. Meticulous work ethic and a collaborative team spirit.