岗位职责:

1. Lab test raw data and report review of medical device biocompatibility testing; 30%

医疗器械生物相容性测试有关实验室数据和测试报告的核查确认

2. Test plan and project risk assessment under specific guideline; 10%

依据相关指导准则完成对测试方案和项目风险的评估

3. Evaluates and summarizes biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards; 10%

评估分析生物相容性和毒理学有关数据以确保符合相关法规标准要求。

4. Summarize literature searches and perform biocompatibility gap analysis;10%

总结文献检索结果并进行生物相容性差异分析

5. Technical support and exchange experience with lab test staff and sales 10%

同实验室测试人员和销售人员对项目经验的分享并提供相应技术支持

6. Evaluate and determine biological relevance of unexpected results 10%

评估并确认测试中不良结果的生物学相关性。

7. Work with lab engineer and sales for new capability and test business developing.10%

协助实验室工程师和销售人员对测试能力拓展和新业务开发。

8. Other duties related to MHS testing business in biocompatibility and NAM field and accreditation tasks 10%

其他同生物相容性测试业务和无源医疗器械认证领域相关的职责

任职条件:

1. Bachelor’s degree above in fields of Biological Chemistry, Materials Science, Toxicology or relative discipline; Master’s degree is preferred.

本科以上学历,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 3-years biocompatibility relevant research experience. Ability to develop biological safety documents and reports that are compliant with applicable standards and regulations.

至少3年以上生物相容性相关经验, 能够按照标准和法规的要求准备生物安全文件和报告

3. Basic knowledge in biocompatibility and related standards e.g. ISO 10993 series. Familiar with EU, FDA medical device regulations is a plus

具备生物相容性和相关标准的基本知识，如ISO 10993系列标准。熟悉欧盟，美国医疗法规的优先。

4. Knowledge of ISO17025 and OECD GLP principles is a plus;

有实验室质量体系ISO 17025和GLP体系经验的优先。

5. Good project management and client management skills

良好的项目管理和客户管理能力

6. 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

7. Specialist in English writing and listening

英语听说读写能力强