R&D Regulatory Affairs Manager --某欧洲知名医疗器械(上海)有限公司




Ø Ensure company X-Ray productsand process compliance with relevant and international laws and regulations.


Ø Establish and maintain productmarket clearance and other compulsory certification process.


Ø Responsible for marketclearance and other compulsory certificate for new product.


Ø Communicate with Governmentoffice and company internal relevant organization to set up a network toimprove market clearance process


Ø Cooperate and Coordinateclosely with new project team to ensure market clearance and other compulsorycertificate process smoothly and efficiently.


Ø Well communicate with businessunite about the progress and status.


Ø Responsible for coordination offactory inspection from third party.


Ø Act as consultant internally onproduct regulatory and ensure regulatory requirements as fulfilled.


Ø Manage and coach people inregulatory group to have well performing team






Ø Professional knowledge onrelevant standards and regulations; ISO9001, ISO13485, QSR, MDD


Ø Experience in Regulatoryaffairs and networking to authorities


Ø Success experience in severalclearance projects


Ø Good communication withinternal and external department, leading a group to perform certain tasks andachieve setting goals.


Ø Good communication skills withforeigner.