• 无工作经验
  • 招1人
  • 11-09 发布
  • 五险一金
  • 员工旅游
  • 年终奖金
  • 绩效奖金
  • 专业培训
  • 通讯补贴
  • 餐饮补贴
  • 弹性工作
  • 定期体检

职位描述

职位描述: 岗位职责:1、 负责医疗器械相关产品的注册,包括制订注册计划、撰写注册产品标准及申报资料、资料的提交、样品检验、评审及审批的跟进、取得上市批件;2、 负责医疗器械临床试验的协调、实施和管理;3、 负责与客户的沟通,与审评中心及检测中心的咨询与沟通。与检验、测试、认证机构保持密切联系,建立良好关系,开展相关工作,确保产品的注册检验和质量标准复核的顺利进行;任职要求:1、 医学或相关专业本科或以上学历;2、 熟悉医疗器械相关法律法规政策;3、 5年以上医药或医疗器械行业工作经验;4、 有骨科、介入等产品注册经验者优先。 职能类别: 医疗器械注册

联系方式

松江民强路1525号

公司信息

朗迈医疗集团由一群对中国医疗器械市场抱有极大热情的专业人士创立,公司位于中国上海,古老国度和现代文明相会的地方。 2012年7月,上海朗迈医疗器械科技有限公司(朗迈科技/SLMT)成立,公司一直专注于骨科微创,特别是脊柱微创和运动医学领域的产品设计与开发,并致力于提供微创脊柱和运动医学的整套解决方案,是一家集研发、制造、销售和服务于一体的创新型企业。公司尤其专注于行业领先的新技术,并将其运用于公司的产品设计开发中,目前,公司已申请国家专利10余项。 公司将依托专业化的研发及市场团队,契合中国市场,将组合国际及国内最优秀的产品,为客户和市场提供专业的培训,教育和推广等解决方案。 此外,朗迈医疗集团还提供医疗器械最新科技进入中国市场所必需的产品注册咨询和业务拓展服务,同时致力于将中国优秀的医疗器械和诊断产品推广至国际市场,特别是新兴市场及对于控制医疗预算和确保临床疗效有较高要求的市场。 朗迈医疗集团(Legend Medical Group)公司下辖三家子公司:分别是专注于研发制造和分销的上海朗迈医疗器械科技有限公司(朗迈科技/SLMT);专注于植入类产品的终端销售和推广的上海朗迈医疗器械有限公司(朗迈医疗/SLM);专注于新兴齿科技术分销和市场开拓的上海朗昳齿科医疗科技有限公司(朗昳齿科/SLD),诚招有识之士,共同开创企业美好未来。 Legend Medical Group (LMG) is set up by a team of Chinese people who are enthusiastic about medical device industry, based in the landscape of China, an old legendary country with new horizon in modern society. Shanghai Legend Medica & Technology Co., Ltd (SLMT) is established in July 2012, the company is specialized in Minimal Invasive Surgery of Orthopedics portfolio, especially in the field of Minimal Invasive Spine Surgery, we identify ourselves as an innovative start-up medtech company. We elaborately organize our QA &RA team, Product Management Team and Sales Team, we offer intensive professional education, training and promotion to the market. More than this, SLM offers service and business development to emerging technology in MD&D industry, which is looking for entering China market. We are also dedicated to improving the quality of life by sourcing best medical device and diagnostics products in China and introducing to international market, especially to emerging markets and markets are required to control the healthcare budget while keep the equivalent clinical outcome. Legend Medical Group(LMG) has three independent subsidiary companies: Shanghai Legend Medical & Technology Co., Ltd (SLMT) specialized in developing and marketing minimal invasive orthopedics products, Shanghai Legend Medical Co., Ltd (SLM) specialized in the distribution of medical disposables, working with the worldwide leading companies, LengeDental(SLD) focuses on cutting-edge dental implant new business development. We're cordially looking forward to meeting young talents from the industry and let's make things happen.

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