About this role
Regulatory Affairs Specialist
This position is responsible for assisting RA department, include but not limit to getting market clearance for Getinge products, contacting factories and NMPA, and other RA operation related work.
Job Responsibilities and Essential Duties
- Prepare the documents for NMPA review: Request the registration documents from factory side; Preparing the documents for NMPA review (20%)
- Follow up the testing houses: Finding the qualify NMPA and local NHFPC testing houses to do the type testing for registration. Follow up the type testing and push NMPA and local NHFPC testing houses to provide us the testing report (20%)
- Communicate with technical reviewer: Follow up the technical review for our products. Answer the questions from CMDE and local NHFPC review center (20%)
- Upload all certificate and testing report and testing protocol to our web site: upload all certificate and testing report and testing protocol to our web site (10%)
- Support for other daily RA operation work (20%)
- Other responsibilities as directed by line management (10%)
Minimum Requirements
- Bachelor degree or above in any majors, background of biology or medical science related professional is preferred
- Fresh graduates with good background are acceptable, relevant work experience in regulatory affairs of medical device or Pharmaceutical industry is preferred
- Basic knowledge for China medical device registration is preferred, willingness to develop in medical device quality or regulatory affairs field.
- Proficient in the use of MS office suite
Required Knowledge, Skills and Abilities
- Good teamwork spirit and communication ability
- Common communication in Chinese and English
- Carefulness, preciseness, strong sense of responsibility and team work.
- Be able to manage multiple tasks and perform with accuracy and a high attention to detail.
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
About us
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.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.