Regulatory Affairs Specialist for Medical Devices

4 weeks ago

Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full time

We are a team of experts in regulatory affairs at Siemens Shanghai Medical Equipment Ltd., dedicated to ensuring our medical devices comply with international and national standards.

As a Regulatory Affairs Specialist, you will play a crucial role in ensuring our products meet the necessary regulatory requirements. Your responsibilities will include:

Key Responsibilities:

  • Ensure product compliance with relevant international and national laws and regulations
  • Catch up-to-date on regulatory changes and updates to implement in related SOPs and products
  • Establish and maintain product market clearance and other compulsory certification processes
  • Responsible for market clearance and other compulsory certificates for new products and transferred products
  • Communicate with government offices and internal teams to improve market clearance processes
  • Closely coordinate with project teams to ensure smooth market clearance and certification processes
  • Communicate progress and status with business units
  • Coordinate factory inspections from third-party organizations
  • Organize cross-functional RA workshops, including global RA workshops
  • Share knowledge of regulations within the team
  • Other tasks assigned by supervisors

Requirements:

  • 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 (National Medical Products Administration)
  • Good experience with medical device testing and technological requirements is preferred

About Us:

We are a global leader in medical technology, employing over 71,000 Healthineers across more than 70 countries. Our portfolio is crucial for clinical decision-making and treatment pathways. We believe in creating better outcomes and experiences for patients, everywhere.

What We Offer:

  • A competitive salary of around ¥250,000 - ¥350,000 per year
  • The opportunity to work with a global team of experts in regulatory affairs
  • Professional growth and development opportunities
  • A supportive and inclusive work environment
  • The chance to make a real difference in the lives of patients

Why Join Us:

We value diversity, equality, and inclusion, and strive to create a workplace where everyone feels valued and respected. As an equal opportunity employer, we welcome applications from individuals with disabilities. Please join our talent community and subscribe to personalized job alerts to stay informed about new opportunities.

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