• 无工作经验
  • 招1人
  • 11-09 发布

职位描述

职位描述: ?Coordinate, compile, and submit new device applications to the regulatory agencies.协调、整理新设备注册申请并向监管机构进行提交?Review, edit and proofread regulatory documents for submission. Track of status and progress of regulatory documentation对须提交的注册文件进行评估、编辑和校对。实时跟进注册文件的状态和进展情况。?Ensure compliance with regulatory agency regulations and interpretations.确保注册工作符合监管法规及相关解释。?Prepare responses to regulatory agencies' questions and other correspondence.就如何回复监管机构的问题及其它质询进行准备。?Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.收集并整理法规信息及相关指导意见以使注册申请能够符合要求。?Provide solutions to a variety of problems of moderate scope and complexity.为特定范围及复杂程度的各种问题提供解决方案。?Organize and maintain reporting schedules for new device application.组织和确保对新设备申请的进度进行汇报。?Maintain and renew of existing registrations.现有注册的维护和更新。?Involved in related product inspections and coordinate with international teams to solve relate issues.负责产品检测并与国外同事协调解决检测中出现的问题。?Assist in preparation and review of labeling, SOP's, and other departmental documents.协助对标签、流程文件及其它部门文件进行准备及评估。?Participate as an active team member of project teams as required.必要时作为项目组成员参与工作。REQUIREMENTS资历要求?Bachelor above degree majored in medical related specialties本科以上学历,医学相关专业?More than 5 years regulatory affairs working experience with around 3 years focusing on medical device field5年以上注册事务工作经验,3年左右医疗器械领域工作背景?Familiar with imaging products preferred熟悉影像产品者优先?Working background in MNCs preferred跨国企业工作背景优先?Good communication and interpersonal skills良好的沟通和人际交往技巧?Fluent English (verbal and written forms)流利的英文(口头及书面) 职能类别: 医疗器械注册

联系方式

北京市朝阳区霄云路38号现代汽车大厦22层

公司信息

Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments. There’s never been a more exciting time to join us. 豪洛捷是一家领先同侪,集研发、制造和供应优质分子诊断产品和服务、医疗影像系统、外科手术产品于一体的公司,以服务全球***医疗健康需求为己任。豪洛捷公司致力于通过早期诊断、微创的治疗方式帮助全球***得以享受更健康、更长寿的生活。目前hologic亟需优秀人才的加入。 Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. 有远见的人一起致力于健康诊断成就了今天的Hologic。我们坚信,人才是公司宝贵的财富,只有通过招聘、培训、发展、保留最优秀的人才,我们才能持续成功。 Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare. 我们的工作氛围是促进创新和以客户为中心。我们为员工提供最先进的工具和技术,合作和充满激情的工作环境,以提升世界各地的医疗保健水平。 We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues. 公司总部位于马萨诸塞州,在北美、欧洲、拉丁美洲、澳大利亚、亚洲设置了运营中心。我们将集中公司资源致力于提升全球的健康水平。 We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today. 我们正在迅速成长,我们将更加关于于人民、成长与未来。这是一个激动人心的历史时刻,可以访问我们的网站以了解更多的职业生涯的机会。 Hologic has commercial organization, R&D, MFG facilities in China. China Headquarter is in Beijing. We aim to build China Organization an exciting place to work and grow professionally. 豪洛捷在中国设置了完整的商业机构,包括研发、生产等。总部位于北京,我们致力于打造积极的、专业的商业运营机构。

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