QA&RA Manager 北京

月薪： 2-2.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： JOB RESPONSIBILITES-Review the complaints of external customers to improve quality policy and standard.-Develop and maintain quality system, including Chinese Label and Manual Quality Management, Product complaint, Adverse Event, Recall handling, internal quality audit and management, distributor interface with corporate QA management etc.-Set up registration plan based on the business needs, ensuring the business compliance with national regulations.-Familiar with CFDA regulations, process, document review principle and technical requirements. Review registration dossier as internal examiner and guide the project team members to prepare registration documents.-Prepare regulatory submissions and obtain regulatory permits, including import/export clearance in a timely manner-Interact with and build rapport with regulatory agencies and notified bodies as required to perform effective and fast track approval of product registrations.-Monitor the regulation development and regulatory trend in China, report the impact to the company.-Organize and deliver regulatory education and dissemination of regulation information to the organization.MINIMUM REQUIREMENT1.Bachelor degree or above in clinical laboratory, health/life science discipline or the equivalent knowledge and experience;2.Solid knowledge and experience in RA of medical device (IVD preferred), ISO knowledge is preferred.3.Minimum 5 years of professional experience in a regulated environment; solid relationship with authority and office.4.Rich experience in product regulatory submissions and successful registration track record;5.Strong interpersonal skills, sense of innovation, competency in coaching, team collaboration6.Fluent in English and Microsoft office skills 职能类别： 医疗器械注册

联系方式

朝阳门内大街南竹竿胡同2号银河SOHO D座50723室

公司信息

德国美天旎生物技术有限公司是一个以细胞分选技术著称、提供从基础科研到临床应用的完整产品线及完美解决方案的多元化公司。自1989年公司成立以来，美天旎的产品线不断扩充，已经从细胞磁性分选金标准的公司成长为拥有从基础科研到临床治疗完整产品线的专业公司，我们提供样品制备、细胞分离和流式细胞分析、分子分析、细胞培养和细胞治疗、免疫吸附治疗相关的试剂、仪器及服务；公司队伍不断壮大，现有1500多名员工，在20个国家设有分公司或代表处。美天旎以“提高科学认知、促进人类健康”为己任，以"科学家服务于科学家"为口号，以满足客户需求的源动力，通过整合研究、开发和制造过程，不断推出一系列的优秀产品，从独特的MACS细胞标记试剂、复杂的细胞分离和分析设备到创新性的临床应用研究系统。从科研工具到GMP级的试剂，美天旎提供了跨领域的应用产品，比如细胞治疗产品就是我们跨学科专家团队共同研究的成果。 美天旎重视对人才的培养，我们将为您的职业生涯提供一个很好的机会和平台，而不只是提供一份工作，每位员工都至少去德国总部培训一次，提高对产品的深入理解和认识。公司在北京、上海和广州设有办事处，方便全国各地客户的覆盖。随着公司的发展，我们热切盼望有热情、有能力的您一起来分享我们在推动科研进展和满足临床应用研究的热情。

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