Regulatory Specialist 注册专员

面议 北京东城区 1-2年 本科 全职
罗氏诊断产品(上海)有限公司 2016-12-14 更新 2017-10-13 截止

Regulatory Specialist 注册专员

职位描述
职位概述 Job Summary :
1. Establishes and maintains the good and closed relationship with SFDAtesting centers. And successfully gains product registrationcertificates per registration forecast plan.和全国各SFDA检测中心保持良好关系,依据公司产品上市计划及时取得进口产品注册检测报告。
2. Establishes and maintains the good and closed relationship withhospital IVD departments (clinical Lab, drug monitoring lab, GCP,etc…). And builds up and represents Roche Diagnostics’ good image, andgain products clinical trial reports per action plan.建立并保持与IVD临床机构(检验科,药剂科,药理基地 等)的良好关系,树立公司形象,并及时取得临床试验报告。
3. Monitors and reports on local regulation changes and its impacttogether to company. Assists manager to handle daily work in RegulatoryDep.将信息和政策导向及时通知公司。协助经理处理日常法规问题

主要工作职责 Main Tasks & Responsibilities :
1. Works with sales and marketing dep. to fulfill product registrationplan. Achieves RD expectation on productregistration.与销售和市场部配合,完成注册计划。达到公司对产品注册的要求。
2. Establishes and maintains the good relationship with key contacts.Recommends valuable suggestion tocompany建立并保持与政府部门及重点客户的良好关系,为公司提供有价值的意见。
3. As a member of RD, provides active and strong regulatory supports tointernal dep. as needed.作为团队的一分子,积极为各部门和内部员工提供及时和有力的政策法规的支持。
4. Initiatively deals with daily works. Keeps records. Has clear filingand maintain of all documents.积极主动处理其他日常法规问题。做好工作记录。文件分类归档,保留完好。
5. Other projects or tasks assigned by line manager其他主管指派的任务。
6. Conducts business in full compliance to Behavior in Business andBehavior in Competition遵循商业行为准则,合法合理开展业务活动。

教育背景 Education :
Bachelor degree or above, subject on Medical/bioengineering/ clinicalMedicine or biochemistry .
大学本科以上学历,医学/ 生物工程/ 临床或生化专业.

工作经验 Experience :
1. Have not less than 2 years about experience in medical regulatoryaffairs, focus on testing center and clinical trial. Understand IVDproducts’ Standard like industry and national standards( YY andGB)有2年以上医学法规领域的经验 ,有检测和临床经验优先。 了解IVD产品标准(行业和国家标准)。
2. High enthusiasm and devotion, work hard and earnest具有强烈的事业心,工作仔细认真。
3. Willing to work under pressure, self-starting andself-inspiring能承受高强度的工作压力,积极主动并自我激励。
4. Be honest and open, excellent interpersonal communication skill,ability of social activity and collaboration为人诚实、开朗,善于与人沟通和合作,有较强的社会活动能力。
5. Innovating with good independent working ability 在工作中不断创新,能独立处理问题。
6. Energetic team spirit有团队合作精神。
职位要求
  • 本科

  • 1-2年

工作地址

北京东城区

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联系人
廖经理 china.diagnostics@roche.com
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