上海招聘

职位描述：
Main Responsibilities:
1.制定中国地区新产品注册计划，与监管部门保持密切的关系，确保产品按计划获得批准；保证已获证产品的按期延续；
Make the registration plan of new products each year and remain good relationship with related government agencies to ensure the new products license can be approved timely, expiring products are the same.
2.协助团队成员和总部及国内相关部门沟通，收集准备注册资料
Communicate with global & China related departments to collect the materials for registration documents & samples preparation
3. 随时跟进政策法规的变化，提前预警、分析并提供有效措施应对监管政策确保监管的变化；
Have sharp insight and can be pre-warn ,analysis the changing regulations.
4. 承担医疗器械监管政策法规宣传任务，向公司各部门提供医疗器械监管的政策法规信息、注册的状态等
Can be regularly introduce the new policies and regulations, registration process to related departments.

Requirements:
1.本科以上学历，医学背景，听力学更佳
Bachelor or above, major in audiology, medical or pharmaceutical related subject
2.7年以上医疗器械行业注册工作背景，2年以上团队管理经验
Minimum 7 years working experience in medical device regulatory affairs,at least 2 years team management will be prefer.
3.良好的沟通能力，能承受一定的工作压力
Good communication skills, able to work under pressure, delivery orientated 举报 分享

about us

oticon is part of the william demant holding group, a danish owned company with more than 5,000 employees worldwide and revenues totaling jpy 100 billion. oticon's products are distributed in more than 100 countries, and 95% of group revenues are generated outside denmark. we have more than 100 years of experience in the hearing aid business, and today the william demant group is one of the world's leading manufacturers of hearing aids. we have secured this position by being experimental, creative and effective in finding new solutions. and we work together towards a common goal: to provide people who wish to improve their hearing with the best solutions.

oticon始建于1904年，总部设在丹麦首都哥本哈根，是具有百年悠久历史的跨国专业听力集团，在全球拥有50多家子公司以及近90家***的独家代理商。产品从医疗诊断仪器、辅助听力设备、调频语训系统、个人通讯设备到计算机软件等，涵盖整个听力学领域。作为全球听力行业的领导者，奥迪康获得众多国际大奖，产品质量上乘获得业界人士及全球用户的一致好评。奥迪康秉承以人为本的企业文化，致力于研发更多革新技术和有效的听力解决方案，与全球听力专业人士及最终用户分享知识与经验。

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