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职位介绍: Job Responsibilities 岗位职责：主导产品风险管理活动（符合 ISO 14971/GB/T 42062）。同时负责医疗器械全生命周期的技术文档编写与管理。系统识别、评价、控制产品从研发到上市后的各类风险，撰写并维护风险管理报告。确保使用说明书、服务手册等技术文档准确反映产品技术状态并满足全球法规要求；与研发、注册、质量、生产、售后等团队紧密协作，支撑产品全球注册。 1. Lead product risk management activities in compliance with ISO 14971:2019 (GB/T 42062-2022), establishing and maintaining risk acceptability criteria. 主导产品风险管理活动，符合 ISO 14971:2019 (GB/T 42062-2022)，建立并维护风险可接受性准则。 2. Develop, update, and maintain technical documentation for medical devices (e.g., Instructions for Use (IFUs), Service Manuals, Design Change Notice), ensuring content accurately reflects product technical status. 编写、更新和维护医疗器械技术文档（如使用说明书、服务手册、设计变更文档等），确保内容准确反映产品技术状态。 3. Systematically identify, evaluate, and control risks throughout the product lifecycle from R&D to post-market, preparing and maintaining the Risk Management Report. 系统识别、评价、控制产品从研发到上市后的各类风险，撰写并维护《风险管理报告》。 4. Ensure technical documentation (e.g., IFUs, Service Manuals) accurately reflects product technical status and meets global regulatory requirements. 确保使用说明书、服务手册等技术文档准确反映产品技术状态并满足全球法规要求。 5. Collaborate closely with R&D, Regulatory Affairs, Quality, Manufacturing, and Service teams to support global product registration. 与研发、注册、质量、生产、售后等团队紧密协作，支撑产品全球注册。 6. Manage multilingual translation processes (including editing, review, and localization) to meet regulatory and marketing requirements in target markets. 管理多语言翻译流程（包括编辑、审核与本地化），满足目标市场的法规及营销需求。 7. Monitor and implement regulatory standards (e.g., ISO 13485, NMPA, FDA, MDR) to ensure global compliance of documentation. 跟踪并实施 ISO 13485、NMPA、FDA、MDR 等法规标准，确保文档符合全球监管要求。 8. Integrate feedback from stakeholders, continuously update document versions, and manage end-to-end document lifecycle control. 整合各方相关方反馈，持续更新文档版本，管理全生命周期文档控制。 9. Utilize ERP systems, Product Lifecycle Management (PLM) tools, MS Office, and related software to efficiently complete documentation tasks. 使用 ERP 系统、PLM 工具、MS Office 等软件高效完成文档任务。 10. Lead risk analysis activities during product development (e.g., preliminary hazard analysis, FMEA, FTA), identifying hazards, hazardous situations, and harms, and evaluating risk levels. 在产品开发阶段主导风险分析活动（如初步危险分析、FMEA、FTA），识别危险源、危险情况及伤害，评价风险等级。 11. Conduct formal risk-benefit analysis for residual risks that cannot be reduced to acceptable levels, forming the core justification for product release. 针对无法降至可接受水平的剩余风险，牵头进行正式的风险-收益分析，形成产品上市的核心论据。 12. Establish and operate post-market risk monitoring systems (complaints, adverse events, literature, similar product recalls), periodically review risk management files, and trigger CAPA when needed. 建立并运行上市后风险监测系统（投诉、不良事件、文献、同类产品召回等），定期复审风险管理文档，必要时触发纠正与预防措施（CAPA）。 Job Qualifications 任职要求： 1. Bachelor’s degree in biomedical engineering, Electronic Information Engineering, Automation, Mechatronics, Industrial Design, or related engineering fields, with 3+ years’ experience in medical device or pharmaceutical industry. 生物医学工程、电子信息工程、自动化控制、机电工程、工业设计等相关工科专业本科，3 年以上医疗器械或药物行业经验。 2. At least 3 years of direct experience in technical documentation, or 2+ years of direct experience in risk management. Experience with Class III (high-risk) devices is preferred. 至少 3 年直接从事技术文档编写，或2 年以上直接从事风险管理工作经验。有三类高风险产品经验者优先。 3. Formal training and certification on ISO 14971 (GB/T 42062) is required. ISO 13485 internal/external auditor certification is strongly preferred. 完成 ISO 14971 (GB/T 42062) 官方培训并持有证书。持有 ISO 13485 内审员或外审员证书者优先。 4. Familiar with medical device development processes and quality management workflows. Proficient in risk analysis tools such as FMEA and FTA with proven project application. 熟悉医疗器械开发流程及质量管理体系运作，熟练运用 FMEA、FTA 等风险分析工具并有实际项目应用证明。 5. Strong knowledge of regulatory standards: NMPA "Medical Device Registration Management Measures", EU MDR 2017/745, FDA 21 CFR 820 (QSR), and relevant standards like IEC 62366, IEC 60601 series. 熟悉 NMPA《医疗器械注册管理办法》、欧盟 MDR 2017/745、FDA 21 CFR 820 等法规标准，以及 IEC 62366、IEC 60601 等相关标准。 6. Excellent English proficiency (written/spoken) for documentation and cross-border communication; capable of independently writing English IFUs, Risk Management Reports, and PSURs. 优秀英文书面与口语能力（必备），可独立撰写英文版使用说明书、风险管理报告及 PSUR。 7. Proficiency in documentation tools such as Microsoft Word, Google Docs, Adobe series, as well as document control systems, ERP, and PLM tools. 熟练使用 Microsoft Word、Google Docs、Adobe 系列等文档工具，以及文档控制系统、ERP、PLM 工具。 8. Strong attention to detail, ability to manage multiple tasks under deadlines, and cross-functional collaboration/analytical skills. 高度注重细节，能在时限内高效处理多任务，具备跨团队协作与逻辑分析能力。 9. Demonstrated risk judgment and courage to challenge unsafe designs; ability to facilitate risk consensus across R&D, regulatory, and quality teams. 具备审慎的风险判断力，敢于对不安全设计提出异议，能推动研发、注册、质量等团队达成风险决策共识。 10. Experience in agile development or multinational teams preferred; Master’s degree or large-scale medical equipment documentation experience is a plus. 具备敏捷开发或跨国团队经验者优先；硕士学历或大型医疗设备文档经验者优先。

其他信息: 语言要求：英语; 行业要求：医疗器械

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