【苏州注册法规专员（外企外包）No26招聘】-猎头顾问苏州招聘信息-猎聘

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人力资源 · 承德茹国人力资源服务有限公司

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职位介绍: 碧迪：注册专员薪资：10-14K 13薪六险一金朝九晚六双休合同：科锐国际 2年合同稳定续签有机会转正地点：苏州工业园区任职资格：外企医疗器械注册相关背景优先（英语流利的应届生亦可） 1.At least 2 years of MD RA experience, handled multiple projects. 2.Proficient in spoken and written English and Chinese 3.Good communication skills and learning agility 4.B.S. or B.A. degree in a technical discipline (Biology / Physics / Chemistry). 1.Registration Provide regulatory guidance and strategic support to project teams throughout the product registration lifecycle. Prepare and coordinate pre-market submission activities, including sample and document applications, translations, type testing, and registration dossier preparation. Manage and monitor registration timelines, closely tracking project progress to ensure timely regulatory approvals. Ensure timely completion of registration renewals and prevent any registration certificate gaps. Collaborate closely with Global Regulatory Affairs teams to drive China registration projects according to plan. Proactively monitor changes in NMPA regulations, industry standards, and regulatory policies; participate in the development of BD comments and position papers; assess regulatory impacts on assigned projects and communicate risks and recommendations to management and stakeholders. Participate in cross-functional and corporate regulatory projects as assigned. 2.Regulatory Support Provide timely regulatory support to Business Units (BUs) and Marketing teams to facilitate business objectives and ensure project timelines are met. Support the interpretation and communication of regulatory requirements and policies to internal stakeholders. Maintain effective communication with Global Regulatory Affairs teams and provide timely updates on regulatory developments in China. 3.Post-market Support Review and approve labeling, instructions for use (IFU), and packaging materials in a timely manner. Review promotional and marketing materials for regulatory compliance. Provide regulatory support and assessment for post-market activities and issues. 4.Database, Reports & Documentation: Maintain product registration databases and ensure information is accurate, complete, and up to date. Ensure registration documents are filed accurately, completely, and in accordance with internal requirements. Prepare and maintain monthly trackers, regulatory reports, and other required summaries in a timely manner.

其他信息: 语言要求：英语; 行业要求：医疗器械,货运/物流/仓储

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