Regulatory Affairs Principal

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. 

Are you looking for an inspiring career? You just found it.

Job Overview工作概述

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.
该职位负责协助RA部门，包括但不限于根据RA Leader的安排支持洁定产品注册获取市场准入许可，与工厂及中国国家药品监督管理局（NMPA）保持联络，以及其他的RA operation相关的工作。

Job Responsibilities and Essential Duties工作职责和基本职责

•    Prepare the documents for NMPA review: Request the registration documents from factory side; Preparing the documents for NMPA review (20%)
准备NMPA申报材料：向工厂方索取注册所需文件；编制符合NMPA审查要求的申报文档（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%)
跟进检测机构工作：筛选具备资质的NMPA及地方卫健委指定检测机构进行注册型式检验；督促检测进度并确保及时获取型式检验报告（20%）
•    Communicate with technical reviewer: Follow up the technical review for our products. Answer the questions from CMDE and local NHFPC review center (20%)
对接技术审评专家：追踪产品技术审评进度，协调处理审评过程中的技术问题。答复药监局审评中心问询：针对CMDE（医疗器械技术审评中心）及地方卫健委审评中心提出的问题提供专业答复 （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%)
证书及报告归档（10%）：将全部认证证书、检测报告及试验方案上传至公司内部数据库
•    Support for other daily RA operation work (30%)
其他RA部门日常运作相关工作的支持 (30%)

Minimum Requirements任职条件

•    Bachelor degree or above in any majors, background of biology or medical science related professional is preferred
本科及以上学历，生物、医学等相关专业背景优先
•    Fresh graduates with good background are acceptable, relevant work experience in regulatory affairs of medical device or Pharmaceutical industry is preferred
可接受背景良好的应届毕业生，有医疗器械或制药行业注册申报相关工作经验者优先
•    Basic knowledge for China medical device registration is preferred, willingness to develop in medical device quality or regulatory affairs field.
对中国医疗器械注册有基本认识者优先，有意愿在医疗器械质量或法规方面有所发展
•    Proficient in the use of MS office suite
熟练使用MS Office办公软件

Required Knowledge, Skills and Abilities 所需的知识、技能和能力

•    Good teamwork spirit and communication ability
具备良好的团队协作精神与沟通表达能力
•    Common communication in Chinese and English
能够使用中英文进行日常工作交流
•    Carefulness, preciseness, strong sense of responsibility and team work.
细致严谨，责任心强，具有优秀的团队合作意识
•    Be able to manage multiple tasks and perform with accuracy and a high attention to detail.
具备多任务管理能力，工作精准度高，注重细节把控
•    Exercises good judgement in elevating and communicating actual or potential issues to line management.
善于判断问题性质，能及时向上级管理层汇报实际或潜在问题

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.