医疗器械海外注册专员

Medical Device Overseas Registration Specialist
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 2 years of experience in medical device or
pharmaceutical registration, with a record of successful overseas registration
cases, and able to draft registration materials as required.
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.
Salary: 12K – 15K