职位描述
职责描述:
Establish and improve the regulatory documentations.创建并优化注册文档
Responsible for premarket products registration at CFDA, including document preparation, testing, submission and technical review, query answer and etc., to secure license in a good time manner. 产品注册,包括文件准备、检测,递交、技术审查、答疑等,优质按时完成注册
Closely follow up ongoing projects with relate stakeholders. 紧密跟进项目、联系相关部门
Provide Regulatory supporting to BU in key countries of Asia, such as promotional material review, CFDA inspections. 为亚太关键国家提供及时的法规支持,例如宣传资料的审核,药监检查等
Assist manager to maintain and develop current regulatory knowledge of domestic and internationals, guidelines, and standards and apply appropriate implementation strategies.协助直线经理维护法规知识、指导原则和标准,制定策略。
Requirements 要求:
- Bachelor’s degree, major in medical science or related field from an accredited college.医学相关专业,本科以上学历
- Previously experience on medical device company is preferred.医药行业相关经历优先
- Ability to focus on details and accuracy 关注细节、准确性
- Good written English skills.良好的书面英语能力
- Good communication skills, and teamwork ability. 善于沟通、团队合作。
企业介绍
Permobil集团是全球领先的高端电动轮椅、手动轮椅(Tilite)、坐垫(Roho)等产品的生产和服务供应商。集团成立60余年来,一直专注于为客户提供定制化的产品和服务,以最大限度的提高他们的生活品质。集团总部位于瑞典,目前在全球15个国家建立了分支机构,并在70余国家和地区提供产品和服务。