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注册工程师

面议
天津-滨海县 | 3年以上经验 | 本科学历
2024-01-06 更新 被浏览:
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职位描述
招聘人数:1-2人 到岗时间:不限 年龄要求:不限 婚况要求:婚姻状况
语言要求: 英语
1、负责维护已获得CE认证产品的评审;
2、负责编写新产品CE及FD认证所需资料;
3、负责维护已获得FDA认证产品及新产品获得FDA认证的相关工作;
4、对公司相关部门进行法规培训;
5、根据当地法规要求协助供应商在当地进行注册所需文件;
6、更新CE、FDA等国际法规,找出影响企业的法规要求并召集相关部门采取对应的措施。



1、大学本科及以上学历,医学或英语相关专业;
2、了解国家药监局关于医疗产品注册的法规文件精神,具有一定的管理经验和能力;
3、英语听说读写流利,可使用外语作为工作语言;
4、勤奋敬业,具有良好的沟通协调能力;
5、从事医疗类产品注册工作三年以上,能独立完成二类产品注册工作。
求职提醒:求职过程请勿缴纳费用,谨防诈骗!若信息不实请举报。
该公司的其他职位
  • 合资企业
  • 50-200人
  瑞奇外科成立于2005年, 是美国Reach Surgical, Inc. 在华投资的外商独资企业, 是集研发、生产、销售于一体的专业化的外科医疗器械及医疗设备提供商。   瑞奇外科的产品技术立足高端产品平台, 其全线产品均已获得欧盟CE认证, 且RCS 系列端吻合器已经取得美国FDA的产品认证。目前公司在美国Cincinnati, 北京和上海设有三个研发中心, 致力于为全球的临床外科医生提供先进的和高质量的微创外科解决方案。   瑞奇外科拥有一支专业化的市场销售团队, 恪守 关爱生命、创新不止 的信条, 以高品质的产品服务于全球的临床医生和患者。        公司地址:天津经济技术开发区第四大街5号B座四层(泰达医药研发大厦)——瑞奇外科(总部)   上海浦东新区郭守敬路——华外医疗(上海)                    公司网址:http://www.reachsurgical.com/          注:八小时工作制,周末双休                  Reach Surgical (Beijing), Inc., established in 2005, is a wholly owned foreign enterprise invested by Reach Surgical, Inc., a USA medical device company. It is dedicated to providing advanced medical devices and surgical equipments through its global product development centers, manufacturing facility and distribution network in China. Quality matters as we treasure life. Reach Surgical (Beijing), Inc. follows US c-GMP. All our products have CE approvals and RCS series circular staplers have obtained the FDA approval. Reach Surgical (Beijing), Inc. has three advanced R&D centers in Cincinnati, Ohio, Beijing, and Shanghai. We are dedicated to providing the advanced and best solution of minimally invasive surgery for clinical surgeons. "Innovating for life" is what we believe in. With a professional marketing and sales teams, Reach Surgical (Beijing), Inc. is devoting to providing our customers products and services of the highest quality. China Surgical Corporation (Shanghai) is a solely foreign-owned enterprises, a new subsidiary invested by China Surgical (Cayman)Corporation in China. China Surgical ( Cayman )Corporation commits itself in developing, manufacturing and selling advanced surgical operational staplers, and it has three serials of products: 1.Open automatic Staplers 2.Endoscopic automatic Staplers 3.Ultrasonic knife operation system China Surgical Corporation has invested and found Reach Surgical (Beijing) Co., in 2005, thereafter invested and found China Surgical Corporation (Shanghai) in 2007 which is researching, developing and manufacturing micro-port surgical operation instruments. The core of this company is made up of technical and management experts who have worked many years in American top surgical companies with advanced surgical technology and achievement, and this company cooperate with Peking Union Medical College and Beihang University actively, then build a new road to research, study and develop in the surgical field. It has class 100000 cleaning room, various manufacturing equipments, perfect machining means and validating means. Its employees are returnees who receive their education abroad and Chinese professional people, and more than 80% of them are bachelors or above. Guided by the faith  Innovation for life , this company serves Chinese patients by high-quality products, and provides a serial of advanced solutions for Chinese medical organizations in the micro-port surgical field.
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