Asia RA Manager 苏州

月薪： 3-4万/月

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 出国机会

职位描述

职位描述： ?Recommend and maintain quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives?Implement and maintain good manufacturing practices (GMP) and following FDA regulatory requirements by continuously auditing the QA process to meet the established requirements?Ensure compliance with applicable regulations for manufacturing Medical devices in China for both local and export sales?Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.?Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data.?Develop an overall perspective of registration projects.?Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.?Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.?Maintain an up to date knowledge of the relevant legislation in China.?Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.?Provide regulatory advice to company personnel as required.?Be required to participate on special projects for the Regulatory Affairs Group?Attend Regulatory Affairs, Medical Department and other internal meetings as required.?Provide a resource for other sections of the company for specified therapeutic areas. 职能类别： 医疗器械生产/质量管理

联系方式

苏州工业园区

公司信息

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