法规事务主管-RA Supervisor-北京(医疗器械注册)招聘_美国泰利福医疗Teleflex Medical最新招聘信息-猎才医药网

职位描述

职位描述： PART I - POSITION SUMMARY 职位概要?Mainly engaged in registration for imported medical devices (including registration product standards, product inspection, register data preparation and filing), to make sure the progress of application. Lead a team to handle the register process of assigned product line.主要从事进口医疗器械产品注册的相关工作（涉及注册产品标准、产品检测、产品注册资料的准备及整理），确保产品申报的进度。并带领团队掌控负责的产品线的注册进度。PART II - PRINCIPAL RESPONSIBILITIES 主要职责?Be independently responsible for the local registration of medical device products, to ensure registration is processed as plan including:独立地负责公司医疗器械产品在国内的注册，确保产品的注册进程按照计划进行,包括：（1） Coordinate with Marketing, Sales and Global RA, to work out registration plan. 与市场部，销售部，国际注册部进行协调，制定注册计划（2）According to the relevant regulations and standard requirements, draft the product technical requirements（depends on product), follow up product test. Keep in touch with the test institutions closely with a good relationship. Ensure test can be proceeded smoothly.按照相关法律法规及标准的要求，起草产品技术要求(根据产品)，跟进产品检测；与检验、测试机构保持密切联系，建立良好关系，确保注册检验的顺利进行（3）Communication with CFDA, to ensure submission, technical review and administrative approval to proceed smoothly in each application. Tracking product registration process to make sure the certification getting on time.与国家药监局等部门联系沟通，确保各个注册申请的报送、技术审评和审批的顺利进行，实时跟踪产品注册进程，确保按时获证（4）To make necessary change, correction, IFU-Updating after getting the registration certificate.取得注册证书后,如需要,根据实际情况,进行注册证书的变更、纠错、说明书备案的工作?Study and understand local/international regulation, provide detailed suggestion on registration or certification.研究和了解国内、国际的法律法规，为产品注册或认证提供详细的咨询建议?Good Planning & coordinating skill, experience and ability to address problem solving independently including communications with stakeholders including sales and marketing具有良好的计划能力与协调能力，具有独立解决问题的经验与能力，包括与利益相关人（市场和销售）的沟通?Preparation and review of changes to existing products and processes 对现有产品和过程的变更，提供准备和检查?Assistant for Internal and external auditing 协助内部和外部的审计 ?Maintain registration documents in order, file the product data.有序管理产品的注册资料文档，负责产品的资料归档?Independently capable to make the Chinese label and IFU according to CFDA’s requirements根据CFDA的要求，独立地完成制作产品的中文标签和说明书?Provide related document to Commercial, Sales department.提供公司商务、销售部门招投标需要的有关法规文件。?Study and understand local/international new regulations, provide strategic suggestion for amendment and new product registration负责研究和了解国内、国际新的法律法规，为公司的变更、新产品注册提供策略性建议?Familiar with local medical device registration process, regulations and standards, plan with strategy on register documents, timeline and cost etc. Getting registration certificate as company’s requirement on time.熟悉国内医疗器械产品注册流程、行业法规规定及国家标准，能够策略性统筹注册项目文案、时间进程及费用等，根据公司要求按时取得注册证书?As a Leader, to handle the register process for the assigned product line（10-15 products ).作为一个产品线的带领人，掌控负责的产品线的注册进度?Manage people, including: A/ coach and support the team members to complete the submission and approval during the registration process, B/ lead and monitor the team members’ performance to reach China business and regulatory short and long term goal and objective, and to ensure the organization ‘s regulatory affairs are conducted accurately and ethically管理人，包括： A/ 指导并支持团体成员完成注册过程中的递交、取证的工作， B/ 领导并监督团体成员达到中国业务和法规上的短期、长期目标，确保团队的法规事物精确地、合规地执行。PART III – QUALIFICATIONS 任职要求EDUCATION 教育程度?Bachelor degree or above, major in Medical, Medical device, Biomedical Engineering, Electro-mechanics, Materials is preferred大学本科及以上学历，医学，医疗器械、生物医学工程、机电、材料等专业优先；EXPERIENCE 工作经验?7+ years’ experience in registration.有7年(含以上)产品注册经验。 ?Familiar with local medical device registration process, regulations and standards.熟悉国内医疗器械产品注册流程、行业法规规定及标准?Proficient in the use of MS Office suite.能够熟练操作常用办公软件。OTHER QUALIFICATIONS (Physical, Visual etc.) 其他要求?Proficiency communication in Chinese and English有良好的中英文沟通能力?Carefulness, preciseness, initiative and strong rationality, strong sense of responsibility and team work工作作风细致、严谨、主动、条理性强，有高度的责任感和良好的团队合作精神职能类别：医疗器械注册关键字：医疗器械美资外企产品注册法规事务医疗器械注册

公司信息

美国泰利福：成立于1943年的美国泰利福是一家在重症监护和外科领域处于领先地位的跨国企业，全球有超过11000名员工，年销售额为17亿美金。泰利福为全球150多个国家的医疗机构提供高品质多种类的产品组合，目前共有血管通路Vascular Access、外科Surgical、泌尿Urology、心脏辅助CA、麻醉呼吸Anesthesia & Respiratory、专业产品OEM和其他产品六条产品线。我们在全球25个国家建立销售公司和生产基地，并且在美国、马来西亚、捷克和德国建有研发中心。泰利福中国：泰利福在中国的业务已超过20年之久： 90年代初，泰利福以Pilling 品牌进入中国市场； 1996年，泰利福就在北京设立了代表处，开始进入中国市场； 2007年，我们在上海成立了第一家独资企业-泰利福医疗器械商贸(上海)有限公司，标志着泰利福中国进入另一个里程碑发展阶段。长久以来，泰利福一直致力于在血管通路Vascular Access、外科Surgical、泌尿Urology、心脏辅助CA、麻醉呼吸Anesthesia & Respiratory和专业产品OEM和其他产品领域向中国的客户提供安全可靠的医疗耗材产品。我们的一些知名的品牌包括Arrow、 Deknatel、 Hudson RCI、 KMedic、 Pilling、 Pleur-Evac、 Rusch、 TAUT 和Weck。随着公司在中国的业务扩大，我们期待更多的专业人士加入我们的团队。愿景：成为一次性重症监护产品及外科产品领域的国际领先公司使命：通过提供微创、降低感染及高安全性的产品改善临床疗效了解更多信息，敬请关注泰利福官方网站(英文网站） www.teleflexmedical.com 或泰利福中国专属招聘门户网站（中文网站） teleflex.zhiye.com Teleflex Incorporated: Founded in 1943, Teleflex is a global provider of medical devices used in critical care and surgery, with sales revenue of 1.7 billion USD. We have more than 11,000 employees worldwide. We serve healthcare providers in more than 150 countries with specialty devices for Vascular Access, Surgical, Urology, CA, Anesthesia & Respiratory、OEM and others. We have sales operations & manufacture in 25 countries, and set up R&D Centers in U.S., Malaysia, Czech Republic and Germany. Teleflex China: Teleflex China also has a reputation for excellence that spans over 20 years in China. Back to 1996, we founded our first representative office in Beijing. In 2007, we founded our WOFE, Teleflex Medical Trading Shanghai Company Limited in Shanghai, a milestone in the development of Teleflex business in China. For years, we provide disposable medical consumables in surgical, critical care, CA, Anesthesia and Respiratory, and Urology to our Chinese customers. As our business is growing tremendously in China market, now we are looking for more professionals to join us. Vision Statement Create a world leader in disposable medical products for critical care and surgical applications. Mission Statement To enhance patient outcomes by providing products that are less invasive, reduce infections, and improve patient safety. For more information, please visit our website: www.teleflexmedical.com and our recruitment portal: teleflex.zhiye.com

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

北京相关职位

职位描述

联系方式

公司信息