技术文档评审员 (有源医疗器械)

Are you ready to embark on an exciting professional journey where innovation, collaboration, and excellence are at the heart of everything we do? Look no further! We are seeking passionate individuals like you to join our dynamic team. I. Position Summary This position is responsible for conducting technical documentation review in Active Medical Product (AMP). For the purpose of international medical device regulatory approval. 该职位的主要职责是在大中国区范围内针对有源医疗器械产品进行技术文件评审工作，以满足有源医疗器械制造商的国际市场准入要求。 II. Job Responsibilities 1. Conduct technical documentation review according to standard

, 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. 02

   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. 03

   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. 04

   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. 05

   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） III. Job Requirements

6. 01

   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）；

7. 02

   At least 3 years working experience in the field of active medical device; 3年及以上有源医疗器械相关工作经验；

8. 03

   At least 2 years product related quality management working experience(e.g. design, regulation registration); 2年及以上产品相关的质量管理工作经验（例如，研发、法规注册）；

9. 04

   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；

10. 05

    Good communication and interpersonal skills; 具有良好的沟通和人际交往能力；

11. 06

    Can work independently and efficiently, can work under pressure; 能够独立、有效工作，能承受压力；

12. 07

    Good computer skill; 具有良好的电脑操作技能；

13. 08

    Good command of English; 具有良好的英语能力；

14. 09

    Physical condition allows normal working, stable outputs. 身体条件允许正常稳定的工作;

15. 10

    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。 **How to Apply** If you are ready to take the next step in your career and join a team that embraces creativity, fosters innovation, and rewards excellence, we would love to hear from you! Please apply with detailed resume, stating expected salary and date of availability to Human Resources Department by clicking 'Apply Now'. TUV SUD is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Join us on this incredible journey of transformation! For more company information, please visit our webpage [外部招聘链接已隐藏] (Data collected will be treated as strictly confidential and will be used for recruitment purpose only)