This position is an expert of biological evaluation as per ISO 18562,ISO 10993-17 and ICH M7 guidelines, which will include literature-basedresearch and review, exposure modeling, complex data review,investigation of medical device manufacturing practice and usage, andthe preparation of technical summaries and reports.
该职位是ISO 18562、ISO 10993-17和ICH M7指南的生物学评价专家，包括基于文献的研究和审查，暴露建模，复杂数据审查，医疗器械生产实践和使用的调查，以及技术总结和报告的编写。
岗位职责
Role-Specific Duties and Responsibilities 80%
特定角色的职责80%
1.Prepare risk assessments, evaluation plans and reports, in compliancewith ISO 10993-1, ISO 10993-17, ISO 18562 and etc..
根据ISO 10993-1、ISO 10993-17、ISO 18562等标准，准备风险评估、评估计划和报告。
2.Evaluates and summarizes biocompatibility and general toxicology dataensuring compliance with the relevant regulatory requirements and standards.
评估和总结生物相容性和毒理学数据，确保符合相关法规要求和标准。
3.Perform biocompatibility gap analysis and write clear concise report.
进行生物相容性差异分析，并撰写清楚简洁的报告。
4.Perform and summarize literature search.
执行和总结文献检索
5.Facilitate the collection of test data from other TÜV SÜD entities asthey relate to a specific project.
针对特定项目， 协助收集从其他TÜV SÜD分支机构的测试数据。
6.Evaluate and determine biological relevance of unexpected results.
评估并确认测试中不良结果的生物学相关性。
7.Apply and maintain the authorization of BC expert
申请并维护BC授权
Other Responsibilities:20%
其他职责:20%
8.Handle customers and projects: arrange projects in optimal way basedon resources, solve technical queries in sincere attitude, communicatein an efficient way and maintain good partnership with customers andother stakeholders
客户与项目管理：基于资源优化安排项目，以诚恳的态度解决技术疑问，高效沟通，与客户和其他相关方保持良好的合作关系
9.Coordinate between team members and provide technical support to Salesand auditors in BC area.
协调团队成员之间的关系，为销售和审核员提供生物学评价领域的技术支持。
10.Perform other duties related to MHS testing business inbiocompatibility and non-active medical devices area, e.g. handling oftest samples, test reports, etc.
在生物相容性测试业务和无源医疗器械检测领域履行其他相关的职责，比如测试样本、检测报告的处理等
11.Share, exchange experience / standards / technical information withother colleagues
与其他同事分享、交流经验/标准/技术信息
12.Follow QMS requirement of GCN and perform tasks which are assigned bylocal manager and GCN managers.
执行GCN质量管理体系的要求，以及本地经理和大中华区经理交办的任务。
任职条件
1. Bachelor’s degree above in fields of Biological Chemistry, MaterialsScience, Toxicology or relative discipline; Master’s degree ispreferred.
本科及以上学历，生物化学、材料科学、毒理学或相关专业；硕士学历优先。
2.At least 1-year biocompatibility relevant research experience
1年以上生物相容性相关研究经验
3.Basic knowledge in biocompatibility and related standards e.g. ISO10993 series
具备生物相容性和相关标准的基本知识，如ISO 10993系列标准
4.Good project management and client management skills
优良的项目管理和客户管理能力
5.Good team player, problem-solver, self-motivated and able to work independently
良好的团队合作精神，解决问题的能力，自我激励和独立工作能力
6.Specialist in English writing and communication
英语写作沟通流利