Freseniusmedicalcare
Product Center Manager PD fluids
CN · Suzhou · Suzhou, Jiangsu, China · Hybrid in China · Full-time · Mid
UNKNOWN
Salary not stated
AI summary
About the company
费森尤斯医疗（Freseniusmedicalcare），医疗健康领域企业，聚焦透析等医疗产品与服务。
Role overview
该岗位为费森尤斯医疗苏州团队的全职混合办公岗位，负责腹膜透析液相关产品的全生命周期合规、风险管理、注册及质量管控，需对接合规事务，参与研发变更、CAPA及临床相关工作，要求2-3年中国医疗器械/药品质管或注册经验，需配合少量国内外差旅。
Responsibilities
- 履行QMS规定的产品中心经理职责
- 担任相关产品合规（监管/质量/安全）主要联系人
- 评估新产品及现有产品变更的监管要求
- 识别本地市场准入机会
- 定义产品风险等级并负责全生命周期合规
- 主导全生命周期风险管理
- 发起支持CAPA及上市后监测工作
- 负责风险管理文件创建与更新
Requirements
- 工程或科学相关本科及以上学历
- 2-3年中国医疗器械/药品质管、研发或注册经验
- 具备中国医疗器械/药品监管环境知识
- 掌握ICH、ISO、GMP等国际标准
- 具备医疗器械风险管理知识
- 良好的中英文能力
- 熟练使用MS Office 365
- 接受少量国内外差旅及弹性工时
Nice to have
- 透析领域（PD、CRRT）产品知识
- 项目管理基础知识
- 临床评估或研究支持经验
Notes for China-based candidates
- 需在中国境内工作，接受少量国内外差旅
- 需具备良好中英文能力
- 需2-3年中国医疗器械/药品质管或注册经验
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Excerpt
Responsibilities 1) Main tasks: • Fulfill PCM role as described in QMS • Main contact for compliance (regulatory/quality/product safety) of concerned products • Evaluation of regulatory requirements for new developments and changes to existing products • • Identification of opportunities for local…
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