北京 [切换城市] 北京招聘北京律师/法务/合规招聘北京法务主管/专员招聘

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(CMN)是医疗健康市场中感染预防和控制产品的领先供应商。 楷腾医疗公司的产品包括水净化设备、消毒剂、杀菌剂和清洁剂、用于内镜检查和肾脏透析的专业医疗器械清洗消毒系统、主要针对牙科和胃肠内镜市场的一次性感染控制产品、浓缩透析液及其他透析用品、针对医疗和非医疗应用的中空纤维薄膜过滤和分离产品,以及传染病和生物学标本的专业包装。楷腾医疗公司还为其产品提供技术维护,并为传染病和生物学标本的运输提供合规培训服务。
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