Together for
a Better World

Job Responsibilities:

1.Participate in new project development and technical improvements to existing products

2.Design and execute product verification plans — conduct testing, verification, and validation, and analyze and document test results

3.Draft and maintain full design and development documentation, including drawings, bills of materials (BOM), technical requirements, process documents, inspection methods, and test reports

4.Coordinate with contracted R&D or manufacturing partners on technical alignment, process handover, and oversight

Requirements:

1.Bachelor’s degree or above in mechanical design, materials science, or a related field

2.2+ years of experience developing Class II or Class III medical devices

3.Proficient in 3D/2D CAD software

4.Self-motivated, strong sense of responsibility, and good hands-on skills

Job Responsibilities:

1.Manage overseas product registration and submissions (primarily FDA), including collecting, drafting, reviewing, revising, and resubmitting documentation, and following up on international certification processes

2.Handle lifecycle management of registered products (e.g., registration changes, renewals, certificate maintenance)

3.Participate in early-stage product development to provide regulatory compliance design inputs

4.Liaise with drug regulatory authorities, certification bodies, or testing agencies for submissions, certifications, and testing communications

5.Track overall registration progress to ensure smooth execution

6.Monitor official domestic websites for the latest regulatory updates, medical device policies, and national industry standards

7.Support project process optimization, template development, knowledge extraction, and training initiatives

8.Complete other tasks assigned by supervisors

Requirements:

1.Bachelor’s degree or above in biochemistry, microbiology, materials science, pharmacy, or clinical medicine

2.CET-4 English or above

3.Experience completing FDA registration projects

4.Familiarity with ISO 13485 standards and MDSAP

5.Strong communication skills, ability to learn quickly, and a team-oriented mindset