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SSMR MR RA Specialist 国内法规注册专员

Job Description

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?

Then come in and join SSMR as 法规注册工程师/Regulatory Affair Specialist to pioneer breakthrough in healthcare. For everyone. Everywhere.


Your mission and responsibilities:

1.Get the country approvals of China market, which includes creating a project plan, preparing the necessary documents with corresponding experts (e.g. product standard, user manuals etc. ), arranging type test and clinical evaluation, submitting application, and so on.
取得中国市场的国家准入,包括指定项目计划,与相关专家共同准备相应的必要文件(例如,产品标准,用户操作手册),安排型式检测,临床评估,提交申请等等。
2.Monitoring the development and internal implement of domestic and international technical regulations and standards in order to effectively support our business interests
监控本地及国际技术标准和法规的发展和内部实施情况,有效支持公司业务利益。
3.Identify and monitor the mandatory technical standards and regulations that our products need to be fulfill and keep them up to date, and follow up the implementation and compliance.
识别和监控产品需要满足的强制性技术标准及法规并维护更新,及后续的实施与跟进。
4.Maintenance of the license for production and operation in the scope of medical device regulations
医疗器械法规内生产/经营许可证的维护

Your qualifications and experiences:
1. professional NMPA knowledges and NMPA registration 2 years’ experience/专业的中国医疗器械注册知识和两年以上的产品注册经验
2.Perfect technical writer/优秀的技术文档编辑能力
3.Public relations and a project leadership skill is preferred/良好公共关系能力及项目管理技能优先
4.Medical device product knowledge/医疗器械产品知识
5.Perfect English is preferred/流利的英文优先
6.Procedure & standards understanding (ISO9001, ISO13485, QSR, etc.)/程序和标准的理解

Our global team: 
We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture:
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.


Organization: Siemens Healthineers

Company: Siemens Shenzhen Magnetic Resonance Ltd.

Experience Level: Experienced Professional

Full / Part time: Full-time

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