Primary Function of Position:

Provides subject matter expertise to all product labeling activites, to ensure the product label meet with NMPA regulation and China importation requirements.

Roles and Responsibilities:

This position has responsibility and authority for:

？ Interpreate medical device labeling regulation.

？ Provide input for product label design and manual draft, and review them as SME.

？ Responsible to communicate and response any questions with Customs, CIQ, NMPA and Customer.

？ Implement labeling procedure to ensure final product shipment to China.

？ Monitor the labeling activities and implementation internal and external (3rd party agent).

？ Handle post market recall/report activities

Skill/Job Requirements:

Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:

？ Bachelor’s degree

？ 3~5 years experience in the relevant role of medical device product

？ Knowledge of China medical device regulation, such like registration, quality. QA or RA work experience will be preferred

？ Experience to handle importation and communication with Customs and CIQ

？ Be proficient in written and spoken Enligsh.

上班地址：半夏路