岗位职责:

Responsibilities:

工作职责：

1. Conduct technical documentation review according to standard requirements, regulatory requirements, procedures and code of conduct;

按照标准、法规、程序及行为准则实施技术文件评审

2. Maintain customer communication for the allocated customers regarding technical review.

就技术评审方面的要求和客户进行技术交流

3. Support relevant in AMP field for customer service, increase customer satisfaction;

支持有源医疗器械相关的客户服务，提升客户满意度；

4. Know well about all policy of TÜV SÜD , procedures related to medical device business, with qualification as medical device in certain area;

充分理解TUV南德和医疗器械业务相关的正常、流程，保持医疗器械相关领域的审核资质；

5. Maintain and develop skills in the field of standard, regulation, medical device (e.g. familiar with the product knowledge and standard requirements, follow the latest standard and regulation).

保持和提升在标准、法规、医疗器械产品方面的技能（例如：熟悉专业领域的产品知识及标准要求、跟踪标准法规的最新动态）

任职条件:

Requirements:

任职要求：

1. At least bachelor degree with diploma in active medical device related major (e.g. Biomedical Engineering, Electronic Engineering, Automatic Control);

本科及以上学历，有源医疗器械相关专业（例如，生物医学工程，电子工程，自动控制）；

2. At least 5 years working experience in the field of active medical device regarding specific product (e.g. design/regulation registration for patient monitor, infusion pump, medical software);

5年及以上有源医疗器械相关工作经验，包括具体产品经验（例如，和监护仪，输液泵，医用软件等产品相关的研发、注册工作）；

3. Diligence, self-motivation, self-improvement and strong teamwork spirit;

具有勤奋、主动、自我改进以及充分的团队合作精神；

4. Good communication and interpersonal skills;

具有良好的沟通和人际交往能力；

5. Can work independently and efficiently, can work under pressure;

能够独立、有效工作，能承受压力；

6. Good computer skill;

具有良好的电脑操作技能；

7. Good command of English;

具有良好的英语能力；

8. Physical condition allows normal working, stable outputs and business trip as required.

身体条件允许正常稳定的工作、能适应出差；

9.Work experience with medical device standards/regulation (e.g.ISO 13485, ISO 14971, IEC 60601-1, MDD or MDR) is preferable

具有医疗器械标准法规经验（例如，ISO 13485, ISO 14971, IEC 60601-1, MDD 或 MDR）优先。