Freseniusmedicalcare
Technical Leader, Regulatory Verification
CN · Suzhou · Suzhou, Jiangsu, China · Hybrid in China · Full-time · Lead
Salary not stated
AI summary
About the company
费森尤斯医疗（Freseniusmedicalcare），医疗器械行业企业，专注于医疗相关产品的研发与合规，服务全球医疗领域客户。
Role overview
该岗位为费森尤斯医疗的全职岗位，位于中国苏州，混合办公，负责医疗器械中国注册相关的技术工作，对接国家实验室与全球专家，准备注册资料，参与标准制定，主导产品验证及测试工作，需具备多年医疗研发、EMC及RF测试经验，支持团队技术工作并承担内部培训职责。
Responsibilities
- 支持有源医疗器械的中国注册，聚焦型式试验相关任务
- 搭建国家实验室与全球专家的桥梁，收集测试方法/报告满足NMPA要求
- 与中国RA及全球专家协作，准备PTR、CER等注册资料
- 作为全球及中国标准技术专家，参与标准与NMPA指南制定
- 组织执行医疗产品、配件及模块的产品验证工作
- 创建符合内外部要求的验证文件，确保可审计
- 协调设计变更过程中的必要验证措施
- 负责医疗器械EMC测试及无线模块RF合规测试
Requirements
- EE/ME/BM工程或相关专业本科及以上学历
- 至少8年医疗研发相关经验，优先血液透析领域
- 至少5年EMC测试经验，优先医疗器械领域
- 至少5年RF性能测试经验，优先2.4GHz及5GHz频段
- 熟悉ISO 9001、ISO 13485等QMS标准
- 熟悉IEC、GB、YY等相关标准
- 熟练使用万用表、示波器等基础测试仪器
- 具备良好的中英文书面及口头沟通能力
Nice to have
- 具备EMC调试经验
- 具备ISO 17025相关经验
- 熟悉血液透析机等医疗产品知识
Notes for China-based candidates
- 需在中国境内工作，混合办公模式
- 需具备良好的中英文沟通能力
- 需满足医疗研发及测试相关经验要求
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Excerpt
Job Responsibilities 1) Main tasks: • Support China registration for active medical devices, mainly focus on the type testing related tasks • Be the bridge of national lab and global experts, collect the test methods or reports to fulfill the type test requirement of China NMPA; • Work with China…
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