职位详情
绩效奖金
定期体检
年底双薪
交通补助
旅游团建
节日礼品礼金
六险一金
餐饮补贴
周末双休
职责描述：
1.根据市场需求或客户导向制订产品注册策略，确保产品的发行和销售符合当地法律法规要求。
2.负责产品注册计划的编写及执行，并具有项目管理能力，促进注册项目按期进展。
3.负责组织产品注册申报资料的撰写、整理、审核，依据法定程序办理注册申报，并能熟练编写产品技术文档。
4.负责与NMPA能保持良好的沟通关系，确保注册申报审批（包括临床评价、体考等）的顺利进行。
5.跟踪注册进程，能及时有效的解决NMPA提出的各类问题。
6.关注医疗器械法规及监管动态，收集行业相关信息，提供产品生命周期所需的法规与标准，维护产品的合法性。
7.根据公司战略目标和部门业务规划，制定并实施个人能力提升规划，保证业务能力和综合素质的持续提高。
任职要求：
1.本科或以上学历，生物、医学、材料相关专业。
2.1~3年医疗器械注册工作经验，熟悉医疗器械相关法规。
3.工作严谨、自主学习能力强、抗压能力较好、适应能力较好、沟通能力佳。
4.良好的英文表达及书写能力者优先。
5.有无源三类植入器械注册经验的优先。
其他信息
所属部门：国内法规事务部
公司介绍
先健科技官网链接：*****************************
先健是****的治疗心脑血管和周围血管疾病的微创介入医疗器械供应商，集研发、制造和销售于一体。自1999年成立以来，经过十余年的持续快速发展，先健已成长为先天性心脏病介入治疗领域全球**大供应商、中国介入医疗器械研制领域的**企业，为推动全球医疗事业的发展做出了卓越的贡献。2011年11月，先健在香港交易所成功上市。
先健在全球先心病封堵器市场占有**地位，是全球**大先心病封堵器供应商，是金砖四国**的先心病封堵器供应商。此外，先健还拥有多元化的微创介入心脑血管及周围血管医疗器械的自主品牌专利产品。
作为国家高新技术企业以及***博士后科研工作站，先健拥有经验丰富的研发团队，与全球知名医学顾问、知名大学和医院建立了长期、紧密的合作关系，其中包括1项973计划项目、2项863计划项目和2项国家科技攻关项目。目前，先健已获得30多项国内外专利授权，并被授予"深圳市知识产权优质企业"、"深圳市成长型中小企业500强"、"第二届深圳进出口诚信AAA企业" 等荣誉，主要产品分别获得广东省科技进步一等奖和三等奖，以及深圳市科技进步奖等荣誉。
先健总部位于中国深圳，在深圳、北京、上海、广州、荷兰及印度设立了十多个子公司和销售办事处，并建立了由全球150多个经销商组成的销售网络。
公司地址：深圳市南山区高新技术产业园北区朗山二路赛霸科研楼1-5楼
（位于朗山二路南侧，先健公司的南侧是怡宝公司，北侧为海王公司）
附近公交站台：华瀚科技/朗山路口
Lifetech is a developer, manufacturer and marketer of advanced minimally invasive surgical medical devices for cardiovascular and peripheral vascular diseases and disorders.
Lifetech was founded in 1999 and is now the ************** provider worldwide of congenital heart defects occluders and the ********developer and manufacturer of minimally invasive surgical medical devices in China. In 2011, Lifetech listed on the Hong Kong Stock Exchange.
Lifetech has a ********market position for occluders, a device for congenital heart defects. Lifetech is now the ***************provider worldwide of occluders for congenital heart defects, and the ********provider of occluders for congenital heart defects in BRIC countries. Lifetech has a broad portfolio of proprietarily developed minimally invasive cardiovascular and peripheral medical devices.
As a national high-tech enterprise and a Post-doctoral Research Workstation in China, Lifetech has an experienced research and development team and has established long term and close cooperative relationships with reputable scientific advisors and third party institutions and universities. Lifetech has conducted and is conducting over 10 government-sponsored research and development projects, including one research project of China National Basic Research Program, two research projects of China National High-Tech Research and Development Program, and two research projects co-sponsored by the Guangdong province and the Ministry of Education of the PRC. Lifetech received over 30 registered patents and has received several awards, including the “Shenzhen Intellectual Property Strength Enterprise” as well as the “Shenzhen Growth Medium and Small Enterprise ****500” and “The 2nd Shenzhen Import and Export Credible AAA Enterprise”. The main products were awarded the ******class prize of “Sci-Tech Advancement of Guangdong Province” and “Self-developed Innovative Product of Guangdong Province”
Lifetech Scientific Corporation is located in Shenzhen and has over 10 subsidiaries, branches and sales offices in Shenzhen, Beijing, Shanghai, Guangzhou and India. A distribution network has been established for all products, consisting of over 150 distributors located internationally.
