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.