职位描述
该职位还未进行加V认证,请仔细了解后再进行投递!
You should ensure products and quality management system complying with relevant international / national standards and regulations through the entire product life cycle.
1. You will be responsible for medical device registration / homologation in NMPA and other national competence authority. Renew and maintain all licenses and certificates according to business development requirements.
2. You will establish, maintain and optimize product registration / homologation and other compulsory certification process, ensure all documentation for product licensing are properly archived and maintained.
3. You will establish, maintain and improve quality management system. Ensure the quality management system is compliance with ISO 13485, China GMP and other regulatory requirements.
4. You will be responsible for Sub-contractor quality and process management. Regular audit to sub-contractor, include incoming, process and outgoing quality control.
5. You will be responsible for Post market surveillance management. Handling of adverse events, post market surveillance plan and report. Medical device reporting to authority.
6. You will communicate with local authority / NMPA and SHS China RA team for regulatory affairs, and improve the efficiency of product registration.
7. You will coordinate with relevant colleagues for authority quality system audit, factory inspection.
Your qualifications and experience:
1. You have Bachelor’s degree or above, major in Biomedical Engineering, Electrical Engineering, Physics, Mechatronics, Computer Science, etc.
2. You over 5 years’ regulatory affairs and quality management system working experiences.
3. Hands-on MAH experience is plus.
1. You will be responsible for medical device registration / homologation in NMPA and other national competence authority. Renew and maintain all licenses and certificates according to business development requirements.
2. You will establish, maintain and optimize product registration / homologation and other compulsory certification process, ensure all documentation for product licensing are properly archived and maintained.
3. You will establish, maintain and improve quality management system. Ensure the quality management system is compliance with ISO 13485, China GMP and other regulatory requirements.
4. You will be responsible for Sub-contractor quality and process management. Regular audit to sub-contractor, include incoming, process and outgoing quality control.
5. You will be responsible for Post market surveillance management. Handling of adverse events, post market surveillance plan and report. Medical device reporting to authority.
6. You will communicate with local authority / NMPA and SHS China RA team for regulatory affairs, and improve the efficiency of product registration.
7. You will coordinate with relevant colleagues for authority quality system audit, factory inspection.
Your qualifications and experience:
1. You have Bachelor’s degree or above, major in Biomedical Engineering, Electrical Engineering, Physics, Mechatronics, Computer Science, etc.
2. You over 5 years’ regulatory affairs and quality management system working experiences.
3. Hands-on MAH experience is plus.
工作地点
地址:无锡新吴区梅育路112号
求职提示:用人单位发布虚假招聘信息,或以任何名义向求职者收取财物(如体检费、置装费、押金、服装费、培训费、身份证、毕业证等),均涉嫌违法,请求职者务必提高警惕。
职位发布者
RichardHR
上海西门子医疗器械有限公司
- 批发·零售
- 1000人以上
- 外商独资·外企办事处
- 上海市浦东新区周祝公路278号
相似职位
-
行政接待 6000-9000元江阴市 应届毕业生 本科上海库跃科技有限公司
-
齿轮箱装配工 6000-9000元江阴市 应届毕业生 不限上海库跃科技有限公司
-
物流技陪生 6000-8000元江阴市 应届毕业生 本科上海库跃科技有限公司
-
0351LC-查勘定损岗 6000-7000元梁溪区 应届毕业生 不限中国平安财产保险股份有限公司无锡分公司
-
036143-行政支持岗(党建品宣) 6000-8000元滨湖区 应届毕业生 不限中国平安财产保险股份有限公司无锡分公司
-
0361VR-团体渠道业务推动岗(宜兴) 6000-8000元宜兴市 应届毕业生 本科中国平安财产保险股份有限公司无锡分公司