Senior RA Specialist
楷腾医疗设备(中国)有限公司
- 公司规模:少于50人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2018-04-17
- 工作地点:北京-东城区
- 工作经验:2年经验
- 学历要求:大专
- 语言要求:英语熟练
- 职位月薪:10-20万/年
- 职位类别:法务主管/专员
职位描述
Senior Regulatory Affair Specialist
? Department: RA/QA
? Location: Beijing
? Reports to: China RA/QA Manager
Job Description :
To ensure company business objectives achieved through:
1. Initial registration and renewal the products of company (CFDA & MOH);
2. Report to CFDA about product change and get approval timely;
3. Plan and implement internal audit to make sure compliance for both internal and external
requirement on regulatory point of view.
4. Assist manager to follow and help the registration affairs for RA specialist.
Duties:
1. Registering and renewing medical device licenses( CFDA & MOH) and other special
approval on time as per the registration priority list;
2. Quality control the registration application and dossier, follow up the evaluation procedure,
solve problem in registration;
3. Report product change to CFDA: Communication with HQ RA and report CFDA if there is
any change on approved products, arrange gap time solution during the approval time;
4. Assist RA/QA manager for the registration affairs;
5. Plan and implement internal audit to make sure compliance for both internal and external
requirement on regulatory point of view;
6. Maintain Chinese IFU & Label comply with CFDA & MOH requirements;
7. Responsible for supporting CFDA & MOH inspection;
Qualification / Experience/ Skills Required
1. Excellent communication skill and interpersonal skill;
2. fully understand CFDA regulation on product registration, marketing supervision and etc
3. Planning and Decision Maketing:
4. With a minimum of 3 years regulatory experience as RA function in medical device industry;
5. Bachelor's degree or above in related mechanical and electro - mechanical expertise
6. background is preferred;
7. Ability to manage projects and timelines;
8. Strong oral and written communication in English;
职能类别: 法务主管/专员
关键字: 医疗器械注册
公司介绍
楷腾医疗公司致力于为患者、护理机构及其他保健服务提供商提供创新的感染预防控制产品和服务,从而改善疗效和挽救生命。
联系方式
- 公司地址:地址:span华夏路16号富力盈凯广场3508室