医疗器械注册专员

欢迎来到泰茂药厂云！

微信公众号

忘记密码？

立即注册

查看入会说明,了解更多详情

当前位置：首页> 招聘服务> 详情

医疗器械注册专员

南京智服医疗器械咨询服务有限公司...

南京

3-4年
本科
12-28 发布

职位信息

职位名称：医疗器械注册专员

类别名称：

职位描述：

职位职能:医疗器械注册岗位职责：1. 负责境外医疗器械产品注册的统筹、协助完成境外医疗器械的立项调研、评估工作。2.根据中国法规要求，起草注册产品标准。3.负责医疗器械的注册申请，包括新产品的注册申请、再注册和补充申请。确保上述注册申请符合国家的相关法规要求，并在公司规定的时限内完成。4.负责注册申请的前期准备工作，包括及时获取注册申请资料及样品；进行注册申请资料的翻译、校对及编写整理；协助注册经理完成注册申请计划的制订。5. 及时汇总、分类、整理、归档国家药品监督管理部门出台的各项法规、文件、技术资料。6. 接听公司内部及外部的咨询电话任职要求：1、本科以上学历，医学或生物学相关专业；2、较强的协调和沟通能力；3、两年以上医疗器械注册经验；4、细心，并能及时有效的完成多种工作任务，5、团队合作者6、语言要求：英语CET6以上，熟练掌握听、说、读、写；Office Admin/Regulatory Assistant for Medical Devices – ChinaWe are seeking for an office assistant, who will take charge of the day to day running of the office and all administrative tasks. Additional duty is to coordinate and facilitate manager with medical device regulatory submissions and international registrations for new products.This is a challenging position for people with passion and learning desire. Opportunity to be promoted as junior regulatory consultant is open.Activities1.Maintain the daily administrative operation for a small but dynamic office2.Support to prepare CFDA dossier (arrangement/file/archive) for medical device registration in accordance with CFDA requirements in timely manner, and support registration manager to complete all procedures.3.Coordinating the collection and transfer of technical data internally to support submissions.4.Maintaining good communication with internal and external stakeholders to ensure timely service delivery.5.Keep updated of CFDA regulatory knowledge.6.Answering phone calls and emailsRequirements1.Bachelor degree or above, chemistry, medicine or biology major desired2.Excellent communication and coordination skills3.Preferablly 2 years’ experience working in regulatory submission or quality control in Medical Devices industry, with sufficient CFDA regulatory knowledge4.Detailed oriented and ability to document effectively and completely.5.Proactive attitude6.Multiple-task management ability7.Team player8.Excellent command of English language, CET 6 aboveThe position is based in downtown area Nanjing, convenient transportation with bus and metro.

任职要求：

收藏本页