Responsibilities:
• Ensure product and process compliance with relevant and international laws and regulations.
• Catch regulations and standards updates, to ensure they could be implemented in related SOPs and products.
• Establish and maintain product market clearance and other compulsory certification process.
• Responsible for market clearance and other compulsory certificate for new product and transferred product.
• Communicate with government office and Siemens internal relavent organization to set up a network to improve market clearance process.
• Cooperate and coordinate closely with new project team to ensure market clearance and other compulsory certificate process smoothly and efficiently.
• Well communicate with business unite about the progress and status.
• Responsible for coordination of factory inspection from third party.
• Coordinate cross RA workshop include global RA workshop.
• Regulation knowledge sharing in team.
• Other tasks assigned by supervisors, i.e. post market RA tasks, and etc.
Requirements:
• Be familiar with China and international regulations on medical devices in registration and development.
• Experience in R&D project quality management or clinical evaluation is a plus.
• Good relationship with NMPA.
• Good experience for medical devices testing and technological requirement is preferred.