Regulatory Affairs Specialist
2 months ago
About Siemens Shanghai Medical Equipment Ltd.
We are a leading medical technology company that pioneers breakthroughs in healthcare. Our mission is to create better outcomes and experiences for patients, regardless of their location or health issues.
Your Role:
As a Regulatory Affairs Specialist, you will be responsible for ensuring our medical products and processes comply with relevant international and national standards and regulations. This includes:
- 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 market clearance and other compulsory certificate processes are smooth and efficient.
- Well communicating with business units about progress and status.
- Responsible for coordinating factory inspections from third-party organizations.
- Coordinating cross-functional RA workshops, including global RA workshops.
- Regulation knowledge sharing within the team.
Your Expertise:
We are looking for a candidate with at least 5 years of experience in Regulatory Affairs. The ideal candidate should have:
- 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 the National Medical Products Administration (NMPA).
- Good experience in medical devices testing and technological requirements is preferred.
Our Culture:
We are a team of over 71,000 dedicated professionals in more than 70 countries. We value diversity, individuality, and collaboration. Our portfolio is crucial for clinical decision-making and treatment pathways.
How We Work:
We believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, 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.
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