Job Description:

1. Responsible for establishing and maintaining registration procedures for target markets (e.g., United States, EU, Japan, Russia) of project-related or corporate platform products, ensuring compliance with relevant local laws, regulations, and standards.

2. Prepare and refine technical documentation for product registration, address any submission-related issues during the process, and ensure successful product approval.

3. Communicate and implement regulatory policies and laws in target markets, lead the identification and evaluation of registration regulations and standards, conduct training sessions on registration regulations, and promptly address any non-compliance.

4. Complete other project tasks as assigned by management based on company needs.

Qualifications:

1. Bachelor’s degree or higher in a science or engineering field.

2. At least 5 years of experience in medical device or pharmaceutical registration, able to independently manage overseas product registration.

3. Excellent command of English (listening, speaking, reading, and writing), with proven ability to translate registration documents for submission purposes.

4. Excellent communication and problem-solving skills.

5. Strong team spirit.