Ensure SSME products and process complying with relevant international and national standards and regulations. Responsible for products registration worldwide.
• Ensure product and process compliance with relevant and international laws and regulations.
• Establish and maintain product market clearance and other compulsory certification process.
• Responsible for market clearance and other compulsory certificate for new product.
• Communicate with Government office and Siemens internal relevant 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.
• Act as consultant internally on product regulatory and ensure regulatory requirements are fulfilled.
• Other tasks assigned by supervisors.
Experience & Education:
• At least 3~5 experience in regulatory affairs.
• Bachelor degree or above.
Organization: Siemens Healthineers
Company: Siemens Shanghai Medical Equipment Ltd.
Experience Level: Mid-level Professional
Job Type: Full-time