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1. 了解国际质量体系标准ISO13485:2016, 了解药监局医疗器械经营监管相关法规,参与质量体系流程的制定和执行
2. 与公司内部各部门协调合作,确保法规、标准和质量体系流程在公司内部得到遵守和执行,如市场部、业务销售部门、运营部、经销商管理,注册临床,技术服务部等。
3. 参与公司内部质量审核,仓库审核及外部质量审核,发现质量体系缺陷及改进机会,并通过纠正预防措施加以改进。
3. 与政府机构密沟通,如上海及北京市级区级医疗器械监管部门,行业协会等,了解法规监管要求及趋势走向
4. 负责公司质量相关系统的注册数据上传和维护工作。
1. Be familiar with international quality system standard ISO13485:2016, and CFDA regulations for medical device, participate the generation and implementation of quality system procedures.
2. Coordinate with internal functions to ensure the regulations, standards and quality system procedures was compiled and implemented, such as marketing, business unit, operations, dealer management, RA&CA, service center, etc.
3. Be connected with external authorities, such as Beijing and Shanghai municipal and district medical device supervision authorities, industry associations, to collect information on medical device new requirements and trends.
4. Be responsible for the registration data uploading and maintenance of quality related software systems.
1. 科学相关专业学士以上学位,医学/化学/电气/生物医学工程类优先
2. 良好的逻辑思维能力
3. 有较好的计划性,以及有效管理项目和优先级的能力
4. 流利的英语听说读写能力,良好的计算机操作技巧和表达能力
5. 有耐心和强责任心,以及团队合作精神
1. Bachelor degree or above in scientific area, medical/chemical/electrical/biomedical major is preferred
2. Well-organized and logical thinking
3. Ability to plan and effectively manage multiple projects and priorities
4. Fluent in both spoken and written English, good computer and presentation skills
5. Patience, a great sense of responsibility and team work spirit