天津招聘

职位描述：
Regulatory Affairs Manager
Are you interested in joining Regulatory Affairs and would like to take a next step for job rotation?
Job description:
· Coordinating global regulatory affairs functional activities to ensure effective support to achieve existing plans and objectives.
· Manage regulatory submission process through to approval, including management and coordination of preparation of all regulatory documentation.
· Write product standard and actively coordinate device local testing
· Involved into change assessment process
· Be part of review process for labelling and marketing documents
· Support Global head of Regulatory Affairs for regulatory training
· Keep up-to-date with the current regulatory environment (medical device)
 
Education level:
You have successfully completed your degree in Biology, Chemistry, Medicine, Engineering or equivalent and have gained practical experience in technical projects (2-3 years).
 
Requirements:
· Fluent in English and German is a plus
· Experienced in international medical device environment
· Good organizational and planning skills
· Good communication skill with local regulatory representatives and distributors
 
We offer an exciting tailored career path for your professional and personal development within our team. You will be accompanied from the beginning with specific coaching and mentoring programs. 举报 分享

 阿尔弗雷德席勒（北京）医疗设备有限责任公司是一家中瑞合资企业，是瑞士席勒（SCHILLER AG)公司在2011年中国投资设立的分公司。作为席勒在中国的总公司我们负责席勒所有产品在中国的市场推广、销售和售后服务等工作，并就产品存在的问题与总部进行沟通，根据客户的使用习惯和要求，反应给总部并进行相应的改进。

    瑞士席勒是一家国际医疗设备生产商和供应商。总部位于瑞士巴尔，席勒在全世界17个国家设有分公司，在100多个国家拥有代理公司为全球用户提供服务。包括美国、德国、瑞士、法国、奥地利和俄罗斯我们都属于心电和肺功能设备生产领域中的领先者。

近年来我们逐步成为国际心电、肺功能、监护和除颤设备的最主要的制造商和供应商。目前我们在80多个国家与当地伙伴共同合作，提供咨询、安装以及用户培训、技术服务和配件的供应。我们在中国同时也对代理商或经销商授权、支持他们的销售和售后服务等工作，并进行相应的监督与管理。

我们的主要产品包括：
除颤/起搏监护仪，AED除颤器
静态心电图仪
动态心电，动态血压
运动心电 运动心/肺功能测试仪
便携式监护仪，磁共振兼容监护仪
静态肺功能仪，运动肺功能测试系统

近年来，我公司产品在部队系统（包括：总后、总参、总装及其他各大军区卫生部）屡次中标，深受用户好评！我们北京席勒公司真诚邀您的加入，谢谢！

公司主页：www.schillermedical.cn