郑州招聘

• Prepare regulatory submissions to NMPA to support new product authorizations and maintain existing licenses; Act as the company representative in regulatory interactions with NMPA
• Prepare internal regulatory documents - including regulatory plans/assessments, product standards, communications, and gap analysis
• Translate regulatory and/or technical documents from Chinese to English and vice versa.

• Develop and execute regulatory strategy/plans, and prepare regulatory submissions for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
• Provide appropriate regulatory guidance and communication to manufacturer’s RA team and local business unit.
• Review marketing/promotional materials and product labelling to meet business needs and regulatory compliance
• Perform gap analysis on NMPA requirement and propose solutions to meet regulatory requirements
• Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements

• Bachelor's degree or above in related scientific discipline; Medical, pharmaceutical, or biomedical/bioengineering background is preferred
• Minimum of 5 years regulatory experience in medical device industry, experience with biomaterials and/or animal tissue-based medical devices preferred
• Demonstrated track record of getting medical device license approvals/renewals in China
• Sound basis of regulatory and scientific knowledge
• Ability to manage complex projects and timelines in a team environment;
• Strong oral and written communication and presentation skills in English and Chinese;
• Demonstrated interpersonal skills including strong negotiation skills;
• Good skill on Microsoft Word, Excel and PowerPoint
• Ability to independently identify compliance risks and escalate when necessary;

库克医疗（cook medical）
库克公司于1963年创建于美国印第安纳州的bloomington。最初以生产血管介入产品为主，也是最早涉足此领域的公司之一。seldinger法血管穿刺、经皮腔内血管成形术等日后对介入诊断与治疗产生根本性影响的技术的推广与普及背后，都有库克公司的卓越贡献。

从建立之初，库克公司便奉行“服务患者，着眼未来”的宗旨，通过自主研发以及与全球***科研机构、医院及专家的合作，不断推出更多创新性医疗产品，服务于患者健康。始终保持在微创诊断与治疗领域的领先地位。

如今，库克公司已发展成为全球规模***的私人医疗器械公司（private company），形成以医疗器械研发与生产为核心，并涉足生物制药、基因与细胞疗法以及生物科技领域的产销一体化跨国集团公司。公司在美国、欧洲和澳大利亚等地设有9大医疗器械生产及研发中心，并在全球主要国家与地区均设有分支机构。产品线也从最初的血管介入迅速扩展，目前主要涉及主动脉介入、心脏介入、急诊医学、消化病学、放射学、外周血管介入、骨穿刺与肿瘤学、外科与软组织修复、泌尿科学以及辅助生殖技术、妇科及产科学等领域，并在多个学科处于领先地位。

库克（中国）医疗贸易有限公司
cook (china) medical trading co., ltd.
库克公司于1996年开始进入中国市场，依托强大的研发和品牌实力，迅速成为最受医生欢迎的品牌之一。2008年，库克公司投资5000万人民币，在上海成立全资子公司——库克（中国）医疗贸易有限公司，以满足国内及亚洲地区迅速增长的医疗器械市场需求。新建于上海外高桥保税区的配送中心占地面积将分期扩充至3500平方米；占地600平方米的客服中心位于上海市区，将负责处理来自我国大陆、香港、台湾，以及韩国、日本、新加坡、马来西亚、印度、菲律宾、泰国、印度尼西亚、柬埔寨、越南等地的订单需求。

如今的库克中国集仓储、物流、配送、客服及销售等各项职能于一体，将作为一个位于上海、面向亚洲医疗器械市场的区域共享服务中心，服务于国内及亚洲市场。

公司主业：www.cookmedical.com

公司网站：http://www.cookmedical.com

联 系 人：grace wang

地 址：北京市朝阳区东三环中路1号环球金融中心东塔1210

邮政编码：100022