Job Description:

?Coordinate the generation, review, approval, tralation, formatting and publishing of product labeling (including product labels, additional labels, Itructio for Use (IFUs) and packaging carto)

?Design, implement, and manage changes to label templates within the IT labeling system (Prisym or jBase)

?Act as a liaison between Cook China Regulatory Affai and various Cook manufacture to align the content of source (English) IFUs with the content of Chinese IFUs and to document appropriate review and approval.

? Manage file trafe and maintai veion control throughout each IFU project, euring accuracy and quality of file content.

?Write and route change requests necessary to introduce or update IFU or label veio into the quality system.

?Investigate label-related customer complaints.

?Maintain relevant electronic data.

?Support quality supervisor to maintain and improve quality system compliance in following sectio in APDC:

Issue and distribute the hardcopy of current veion; collect and destroy hardcopy of obsolete veion in time

Provide document coultation, query and scan iide and outside.

Collect quality related records by requirements of SOP-02-001 and establish list of the records; provide service of query about records.

?Have a sound undetanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements

Qualificatio:

1.Major in Clinical Medicine ( 临床医学), Bachelor or above

2.3-5 yea working experience, medical device industry or Pharmaceutical industry is preferred.

3.Good communication skill in English and Chinese