Senior Regulatory Affairs Specialist

4 weeks ago

Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full time
About the Role

We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at Siemens Shanghai Medical Equipment Ltd. in Shanghai, China.

The successful candidate will be responsible for ensuring that our medical devices comply with relevant international and national standards and regulations.

Key Responsibilities
  • Ensure product and process compliance with relevant 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 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 unit 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
  • At least 5 years experience in Regulatory affairs.
  • 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.
About Us

We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing.

Our portfolio is crucial for clinical decision-making and treatment pathways.

How We Work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas.

We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please join our talent community and subscribe to personalized job alert that will keep you posted about new opportunities.

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