OPPO法规认证工程师
任职要求
1. 背景与资历：本科及以上学历，生物医学工程、电子、医药相关专业；具备3 年以上医疗器械注册相关工作经验，有二类有源产品或医疗软件（SaMD）完整拿证经验。
2. 专业胜任力：精通中国医疗器械监管条例及相关配套规章，熟悉质量管理体系审核流程，具备优秀的合规文件编写能力及技术理解力。
3. 逻辑思维：具备严密的逻辑分析能力，能…工作职责
1. 产品境内注册：负责公司二类医疗器械（含硬件设备及软件产品）的 NMPA 注册申报、延续及变更工作，独立编写综述资料、技术要求等核心申报文档，并跟进产品检测与技术审评。 2. 海外市场准入：参与产品在海外市场（如 FDA、CE 等）的合规准入方案制定，协助准备英文注册卷宗及相关技术文档递交。 3. 质量体系维护：深度参与 ISO 13485 及国内医疗器械生产质量管理规范（GMP）的建立与日常运行，确保产品研发和生产流程持续符合监管要求。 4. 法规风险管控：跟踪国内外医疗器械法规、标准动态（侧重穿戴设备、移动医疗领域），为产品规划提供准确的法规可行性分析及合规风险预判。 5. 外部协调沟通：负责与监管机构、检测机构、咨询机构及内部研发团队的高效协同，解决注册过程中的技术审评意见及疑难问题。
1、跟踪并导入相关区域强制性认证法规，参与认证合规体系建设；评估产品认证需求，在相关产品的硬件、结构或软件开发方面，提供认证合规或技术支持； 2、负责产品的认证策划，制定详细认证计划，评估产品变更影响，提供应对方案，审核产品认证材料和样机，协调开发部、测试部、实验室、认证机构等相关方有效沟通，解决过程问题，保障产品交付达成； 3、负责相关区域认证交付能力及平台能力建设；
THE ROLE As a Regulation engineer, you will overall be responsible for Tesla China market product regulations regarding General Safety, Passive safety， Electric safety etc. Collect, interpret, deliver the involved technical standards and requirements to provide comprehensive and highly efficient product compliance service for various stakeholders incl. Engineering and service center. RESPONSIBILITIES • Attend the working groups meeting, ensure the company's interest can be reflected reasonably, and deliver the interpreted information to the company for safety, EMC etc. areas. • Leading product compliance review. • Analyze and create important report to support management decision making. • Lead un-regulated topics clarification with different authorities.
1. 负责欧盟电池法规与可持续合规战略制定 2. 搭建并完善全球/区域电池合规管理体系 3. 统筹产品碳足迹、LCA及可持续信息披露 4. 负责欧盟市场准入及重大客户合规项目 5. 组织跨部门协同和团队管理。
THE ROLE As a Regulation engineer, you will overall be responsible for Tesla China market product regulations regarding General Safety, Passive safety， Electric safety etc. Collect, interpret, deliver the involved technical standards and requirements to provide comprehensive and highly efficient product compliance service for various stakeholders incl. Engineering and service center. RESPONSIBILITIES • Attend the working groups meeting, ensure the company's interest can be reflected reasonably, and deliver the interpreted information to the company for safety, EMC etc. areas. • Leading product compliance review. • Analyze and create important report to support management decision making. • Lead un-regulated topics clarification with different authorities.