北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医疗器械注册招聘

Product Registration Specialist

爱德士缅因生物制品贸易(上海)有限公司

  • 公司规模:150-500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:2017-06-19
  • 工作地点:北京-顺义区
  • 招聘人数:1人
  • 学历要求:本科
  • 语言要求:英语 熟练
  • 职位月薪:1-1.5万/月
  • 职位类别:医疗器械注册  

职位描述

职位描述:
JOB SUMMARY:

? Responsible for collect the related regulations on Diagnositc kit,Provide basis information for the company's product registration. 负责收集和整理兽医诊断制品相关的注册法律法规,为公司产品注册提供依据
? Responsible for the compilation, examination and standardization of the registered dossier of veterinary diagnostic products. 负责兽医诊断制品注册资料的汇编, 形式审查和规范性制作
? Responsible for tracking the progress of registration ,addressing the issues raised by the experts in the review process. 负责跟踪注册进度,解决审评过程中专家提出的问题
? Responsible for registration document record management. 负责注册资料的归档

PRIMARY DUTIES AND RESPONSIBILITIES:

? Be familiar and keep update with China MOA register regulations and requirements. 熟悉并不断更新中国的注册法规和要求。
? Coordinate to set up register priority and yearly plan. 配合建立产品注册的优先级和年度计划。
? Cooperate with US and EU registration department to prepare the register document, dossier and certificate. 与美国和欧洲注册同事合作,准备相应的注册文件、档案和证书。
? Get products registered and license renew in China MOA according to annual registration plan. 根据年度注册计划,顺利完成产品的注册和再注册工作。
? Keeps records and reports on all activities. 保留所有活动的记录和报告。
? Generates the reports, presentations, or other materials needed. 制作报表,简报或其他所需材 料。
? Other tasks assigned by supervisor.主管安排的其他任务。

MINIMUM QUALIFICATIONS:

EDUCATION:
? Bachelor degree or above. Major in Veterinary /Animal Medicine or related. Master is a plus. 本 科以上学历,研究生优先。兽医/动物医学相关类专业。

EXPERIENCE:
? Product register experience is preferred 产品注册经验优先
? With good knowledge in ELISA, serological tests 具有ELISA和血清学的相关丰富知识
? With PCR and other diagnostic techniques experience 具有使用PCR和其他诊断技术的经验。
REQUIRED SKILLS AND ABILITIES:
? Honest, positive and outgoing personality 为人诚实,性格外向,积极阳光
? Good communication skills and Strong team spirit. 良好的沟通技巧和团队合作精神。
? Good English reading, writing, listening and speaking ability. 良好的英语阅读、写作、听力和口语能力。
? Good proficiency to use office software is required熟练使用办公软件

PHYSICAL DEMANDS:

? Be able to work efficiently under pressure.能够在压力下有效地工作。

WORK ENVIRONMENT:
? Normal office conditions.
WORK LOCATION: Beijing 工作地:北京

职能类别: 医疗器械注册

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公司介绍

美国爱德士(IDEXX)生物科技公司,在兽医、食物及水质检测领域内,一直凭借产品研发创新和高质量服务成为全球领导者。公司总部位于美国缅因州南部,在全球范围内100多个地区进行运营,全球雇员超过8千人。爱德士(IDEXX)公司的主要业务集中在全球范围内快速发展的伴侣动物健康服务;在该领域内,爱德士为宠物医师供综合性产品和服务,包括医院内诊断测试及仪器、参考实验室服务、药物和医院管理软件。同时,爱德士(IDEXX)公司在经济动物,水和奶三个业务领域里施展诊断技术的专长。爱德士(IDEXX)提供创新优选工具,用于监控牛、猪及家禽等经济动物的健康,帮助牧场管理牧场经济影响极大的流行性疾病如:牛病毒性腹泻、猪蓝耳病、禽流感等,提高畜群整体健康水平,提高牧场经济收益;爱德士(IDEXX) 还提供检测饮用水中微生物污染的诊断工具及牛奶中抗生素残余诊断试剂和设备以确保公共水质和牛奶的安全。近年来,爱德士(IDEXX)公司发展迅速并保持2位数的增长速度,2008年全球销量已经超过10亿美圆。2010年, 爱德士(IDEXX)公司延续了快速健康的发展;尤其在亚太地区,取得了巨大的成功。
我们注重人才培养,为员工提供有竞争力的薪酬福利、完善的培训体系和广阔的职业发展空间。

公司网站:*************

IDEXX Laboratories, Inc. is the global market leader in diagnostics and information technology solutions for animal health and water and milk quality.
Headquartered in Maine, IDEXX employs over 8000 people in more than 100 locations around the world.
Our largest business helps more than 50,000 veterinary practices worldwide advance medical care, improve staff productivity and increase practice profitability. We accomplish this via an integrated portfolio of pet-side diagnostic tests, point-of-care instruments, reference laboratory services, digital radiography, and practice management solutions.
In addition, IDEXX is the world leader in microbiology testing technologies that ensure safe water and the top provider of diagnostic tests and health-monitoring systems for milk safety and production animal health.

联系方式

  • 公司地址:地址:span天竺空港工业区B区裕华路28号科技孵化园10号楼1层