【高级注册专员 Senior Regulatory Affairs Specialist招聘】_史赛克(北京)医疗器械有限公司招聘信息-猎聘

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Senior TA Partner · 史赛克（北京）医疗器械有限公司

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职位介绍: Essential Duties & Responsibilities: 1、Prioritize, plan, and review product registrations for respective product lines 2、Prepare, coordinate and submit regulatory applications to the local health authority 3、Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. 4、Provide the management team with regular updates on product registration. 5、Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education 6、Lobby with local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs 7、Support tender operations by timely supply of accurate regulatory documents 8、Establish relationships with local medical device industry groups and work with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies. 9、Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation. 10、Serve as regulatory consultant to marketing team and government regulatory agencies Education & Experience: 1、Bachelor degree in Medicine or Bioengineering or above preferred. 2、Relevant regulatory and quality assurance experiences in international company for more than 2 years Physical & Mental Requirements: 1、Well-organized and logical thinking 2、Good at planning and business processes, 3、Detailed oriented 4、Professional communication skills 5、Patience and a great sense of responsibility

其他信息: 语言要求：英语、普通话; 行业要求：全部行业

公司简介

Stryker是一家医疗技术公司，我们致力于与客户精诚合作，不断提高医疗保健水平。公司拥有骨科植入、医疗设备、神经介入、脊柱等丰富的产品线，可以很好地服务于医生和病患。Stryker在超过100多个国家拥有分支机构。史赛克秉承“在中国、为中国”的理念，在中国地区骨科及外科医疗界，我们不仅仅是一家为客户提供先进医疗器械的供应商，更要做好提供整体解决方案以及病人关怀服务的示范者。

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