Regulatory Affairs Specialist - Mandarin Speaking

Are you a driven and detail-oriented individual fluent in Mandarin? Are you passionate about ensuring compliance and maintaining high standards in the medical device industry? If so, we have an exciting opportunity for you to join the Intuitive Surgical team as a Regulatory Affairs Specialist. In this role, you will play a critical role in obtaining and maintaining regulatory approvals for our innovative surgical products in the Chinese market. We are looking for a highly organized and knowledgeable professional with a strong understanding of Chinese regulatory requirements and a commitment to upholding the highest standards of quality and safety. If you are ready to make a meaningful impact and contribute to the advancement of healthcare technology, we encourage you to apply for this position.

1. Develop and maintain a thorough understanding of Chinese regulatory requirements for medical devices.
2. Collaborate with cross-functional teams to prepare and submit regulatory submissions to obtain and maintain product approvals in the Chinese market.
3. Monitor and track changes in Chinese regulatory policies and guidelines and provide updates to relevant stakeholders.
4. Conduct regulatory research and analysis to ensure compliance with applicable laws and regulations.
5. Review and approve labeling, marketing materials, and other product documentation to ensure compliance with Chinese regulatory standards.
6. Prepare and maintain regulatory documentation, including product registration files, to support submissions and audits.
7. Serve as the main point of contact for regulatory agencies in China and respond to any inquiries or requests for information.
8. Participate in regulatory audits and inspections to ensure compliance with Chinese regulations.
9. Provide guidance and support to internal teams on regulatory requirements and processes.
10. Maintain and update internal databases and systems with current and accurate regulatory information.
11. Identify and escalate potential regulatory issues or risks to management.
12. Continuously monitor and improve processes to ensure efficiency and effectiveness in obtaining and maintaining regulatory approvals.
13. Keep abreast of industry developments and changes in Chinese regulatory landscape to proactively identify potential impacts on the company.
14. Adhere to strict confidentiality and ethical standards while handling sensitive regulatory information.
15. Contribute to company’s mission of providing safe and effective medical devices to improve patient outcomes.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist - Mandarin Speaking in Sunnyvale, CA, USA is $82,000 - $108,000 per year. However, this may vary depending on the specific company, level of experience, and other factors. It is always best to research specific job listings and negotiate salary directly with the employer.

Intuitive Surgical Inc. is an American corporation that develops, manufactures and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System.