1. Responsible for handling registration applications and amendments for the company's medical devices. Complete tasks including drafting and proofreading registration documents, submitting materials and applications, tracking registration progress, conducting system assessments, and systematically recommending registration submission tasks.

2. Maintain effective communication with testing institutes, drug regulatory authorities, and review centers. Timely report relevant situations to direct supervisors. Responsible for receiving review opinions from drug regulatory management departments and making revisions based on feedback.

3. Collect and monitor laws and regulations related to the company's medical devices, and provide training to relevant personnel.

4. Participate in medical device risk assessments, providing evaluation opinions from a regulatory perspective.

5. Assist in preparing R&D validation work required for registration submissions.

6. Continuously track policies, laws, regulations, and product technical documentation related to product development, registration, or certification, providing guidance for new product development and registration.

7. Complete other tasks assigned by the company and leadership.

1. Three or more years of experience in Class II and Class III medical device registration. Experience with active medical device registration is preferred. (Experience with in vitro diagnostic instruments, reagents, systems, or pharmaceuticals does not meet requirements.)

2. Degree in science or engineering; majors in pharmacy, medicine, biology, medical devices, or related fields preferred. Associate degree or higher required, with five or more years of relevant work experience.

3. Familiarity with the registration process and manufacturing procedures for single-use sterile medical device consumables.

4. Familiar with product design development processes and all risk controls throughout the product lifecycle.

5. Capable of formulating and implementing registration plans according to company product advancement schedules, ensuring completion within specified timelines.

6. Familiar with ISO 13485; preference given to candidates holding internal auditor certification or with experience leading medical device registration quality management system audits.

7. Experience in software research or cybersecurity registration preferred.