Regulatory Affairs Specialist

About This Role

This position is responsible for assisting the Regulatory Affairs department, including getting market clearance for Getinge products, contacting factories and NMPA, and other RA operation-related work. This is a two-year contract position, and the selected candidate will be employed by and sign the contract with an external third-party company.

Responsibilities

• Prepare the documents for NMPA review: Request registration documents from the factory side and prepare them for NMPA review
• Follow up with testing houses: Find qualified NMPA and local NHFPC testing houses for type testing for registration, then follow up on the type testing and push NMPA and local NHFPC testing houses to provide the testing report
• Communicate with technical reviewer: Follow up on the technical review for products and answer questions from CMDE and local NHFPC review center
• Upload all certificates, testing reports, and testing protocols to the company website
• Support other daily RA operation work
• Other responsibilities as directed by line management

Requirements

• Bachelor's degree or above in any major; a background in biology or medical science-related professional is preferred
• Fresh graduates with a good background are acceptable; relevant work experience in regulatory affairs of medical device or pharmaceutical industry is preferred
• Basic knowledge of China medical device registration is preferred; willingness to develop in the medical device quality or regulatory affairs field
• Proficient in the use of MS Office suite
• Good teamwork spirit and communication ability
• Common communication in Chinese and English
• Carefulness, preciseness, strong sense of responsibility, and teamwork
• Able to manage multiple tasks and perform with accuracy and a high attention to detail
• Exercises good judgment in elevating and communicating actual or potential issues to line management

Important Details

• Contract: two-year fixed-term

About the Company

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. Getinge employs over 12,000 people worldwide, and the products are sold in more than 135 countries.