Regulatory Affairs Specialist 注册专员
公司名称: 罗氏诊断产品(苏州)有限公司
部门名称: -
招聘人数: 1
发布日期: 2020-03-30
工作地点: 苏州-工业园区

岗位职责:

Job Summary职位概述:


1. Major interface in RDSZ RA team to RDSZ SMEs and RDSL MRA team regarding product registration in China

RDSZ 法规团队里关于产品中国注册相关事项的与RDSZ内部及RDSL法规部的主要联系人


2. Assess development and implementation of regulatory strategies and plans to support timely introduction of RDSZ products in China

评估法规战略和计划的制定和实施,以支持RDSZ产品在中国的及时上市


3. Manage regulatory activities associated with development, manufacturing and marketing of the assigned product portfolio within RDSZ

管理与RDSZ产品组合的开发、生产和营销相关的法规活动


4. Assess and communicates regulatory risks and challenges to project team

评估并与项目团队交流法规风险和挑战


5. Review product files to ensure conformance with regulatory requirements and/or approved products

审核产品文件,确保其符合法规要求和/或批准的产品一致


6. Provide other tasks assigned by the line manager.

  1. 线经理分配的其他任务



Main Tasks & Responsibilities主要工作职责 :



1. Support RDSL MRA to plan RDSZ C4C product registration in China.

协助罗氏诊断上海公司制定罗氏诊断苏州工厂产品的中国注册计划

  1. Plan, lead and executive type testing according to the registration plan, like internal preparation, coordination and supporting QC department to executive the on-site testing, and application by the authorities.
  2. 及在罗氏诊断苏州工厂内部主导产品注册检测,例如内部的准备,协调,及协助QC部门完成现场检测及向相关主管当局提交申请。
  3. Support RDSZ SMEs to generate and deliver submission documents according to registration plan.
  4. RDSZ各部门根据注册计划生成及交付注册用文件
  5. Track, collect and review registration documents incl. type testing report according to RDSL MRA registration plan. Compile and deliver RDSL MRA team the submission binder (RDSZ part).
  6. 产品注册计划追踪用于罗氏诊断苏州工厂产品包括注册检测报告在内注册文件。编辑,整理并向罗氏诊断上海法规事物部输出罗氏诊断苏州工厂的文件。
  7. Update project team and RDSL MRA on registration status and launch plan


向项目团队和RDSL MRA更新的注册状态和上市计划

  1. Cooperate with RDSL MRA team to support RDSZ Quality team the on-site inspection罗氏诊断上海法规部合作,帮助罗氏诊断苏州工厂质量部完成注册质量体系考核
  2. Coordinate RDSZ SMEs to supplement the registration/notification dossiers during technical review period per the requirement from RDSL MRA 罗氏诊断上海法规事务部的要求协调罗氏诊断苏州工厂内相关部门在技术审评阶段补正相关注册/备案资料
  3. Provide primary regulatory opinion to RDSZ SMEs in relation to change, PPM, novel regulatory requirements etc. and support RDSL MRA to complete regulatory assessments为RDSZ各部门提供关于变更、PPM、新法规要求等方面的初步的法规意见,并支持RDSL MRA完成最终的法规评估
  4. Consult RDSZ SMEs to implement novel regulatory requirements at RDSZ like establish new process or generate new document template
  5. RDSZ 各部门提供关于在RDSZ实施新的法规要求的建议,如建立新的流程或生成新的文档模板
  6. Apply other non-product registration related certificate/license, like export certificate, drug importation license etc.

其他与产品注册不相关的许可证的办理, 例如出口证书,药品进口许可等


Qualification & Experience任职资格:


  1. Bachelor, major in biochemistry, immunology, molecular biology, etc. Master Degree is preferred.

生物化学,免疫学,分子生物学等专业本科学历,以上专业硕士学历优先考虑。

2. IVD registration in China experience (Class I - III) (at least 3 years) 3年一类至三类体外诊断试剂中国注册的经验

3. Experienced in regulatory framework for IVD and/or Medical device 体外诊断试剂和/或医疗器械法规方面的经验

4. Good communication skill 良好的沟通能力






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