China Regulatory Affairs manager, IOL 北京

月薪： 20-30万/年

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Major Accountabilities? Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all IOL new products and life cycle management of marketed products in China, aligned with Global Regulatory and Region and Country business strategies and plans.? Monitor operational progression of pre-marketing authorization activities at country level through contact with country regulatory agencies or committees, as required.? Good communication with the country regulatory agencies or committees to expedite new marketing authorization approvals and other operational regulatory interventions.? Ensures all documents submitted to regulatory agencies are complete, well organized, in regulatory compliance, and presented in a manner that facilitates agency review.? Responsible for maintaining records of regulatory submissions and communications with the relevant regulatory agencies.? Work with commercial colleagues to develop promotional strategies and provide regulatory review for promotional materials for IOL products.? Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks.? Monitor and provide regulatory intelligence on new medical device legislation, guidance and policy proposals impacting Alcon’s IOL products or processes. Provide regulatory intelligence on competitive products and companies.?Accountable for ensuring Alcon is adequately represented in relevant regulatory advocacy groups, to ensure the company position is considered as new IOL regulations are proposed by health authorities.BackgroundEducation :Bachelor’s degree in a related field is required.Experience:At least 6 years in Regulatory Affairs, with significant depth of experience within the medical device industryA track record of successful execution of regulatory submissions and approvals for medical devicesHigh energy, collaborative and experience initiating and leading changeAbility to influence senior stakeholders in a global environment 职能类别： 医疗器械注册

联系方式

麦子店西路3号新恒基大厦12层

公司信息

爱尔康（中国） 作为全球眼科领域的领导者，爱尔康的使命是通过创新型产品，提高视觉质量，提高生活品质。这个使命意味着爱尔康22000多名员工为“保护、恢复和提高视力”的目标进行着不懈的努力与奋斗,使散光治疗，青光眼治疗，近视眼激光视力恢复矫正等等技术得到更好，更全面的普及，努力改善更多人的视力健康。 诺华和爱尔康合并后，爱尔康、视康和诺华眼科的优势融合到同一眼科保健业务，爱尔康已成为诺华集团第二大业务部门。公司合并带来的整合资源和业务覆盖的优势，爱尔康现在180个国家销售全线的眼科保健产品，包括手术产品、药品和视力保健产品，并在75个国家拥有分公司。 从一个孩子为矫正近视眼配的第一副隐形眼镜，到她的祖父母为治疗白内障而做的人工晶体植入，爱尔康的创新产品帮助各个年龄段的患者更清晰地看到世界。爱尔康的产品与高科技可用于解决诸多领域里日益增长的临床问题，例如白内障、青光眼、视网膜疾病、屈光不正、眼部过敏、眼部干涩、感染和发炎以及许多其他眼部护理需求。 在全球范围内，爱尔康有近2000名员工致力于研发工作，以满足世界上最迫切的眼部护理需求。同时，我们的业务也延伸到专业教育领域并在整个行业内处于领先水平。

北京相关职位

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北京相关职位： 科技服务部-海外部-运营经理 医药代表/区域经理（职位编号：LZHR206） 分子生物技术员 医学注册部项目经理助理 学术推广经理 临床专员（技术支持） 实验室技术员 抗体药物研发项目经理 产品经理 医药销售代表（心血管治疗领域）

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

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