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

 

Responsibilities:

 

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

 

 

 

Requirements:

 

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.