Senior Regulatory Affairs Specialist
1 month ago
As a Senior Regulatory Affairs Specialist at Siemens Shanghai Medical Equipment Ltd., you will play a crucial role in ensuring our medical devices comply with international and national standards and regulations. Your expertise will be essential in product registration and maintaining market clearance.
Key responsibilities include:
- Ensuring product and process compliance with relevant laws and regulations
- Catching updates on regulations and standards to implement in related SOPs and products
- Establishing and maintaining product market clearance and other compulsory certification processes
- Communicating with government offices and internal organizations to improve market clearance processes
- Coordinating with project teams to ensure smooth and efficient market clearance and certification processes
Requirements include:
- At least 5 years of experience in Regulatory Affairs
- Familiarity 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 in medical devices testing and technological requirements is preferred
Join a global team of over 71,000 Healthineers in more than 70 countries, working together to pioneer breakthroughs in healthcare. As a leader in medical technology, we strive to create better outcomes and experiences for patients, everywhere.
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