丁香人才 > 职位招聘 >医药公司/药店/医疗器械招聘 >医疗设备注册招聘 >上海医疗设备注册招聘 >长宁区医疗设备注册招聘 >Regulatory Affairs Manager招聘

Regulatory Affairs Manager

安迪生物科技(上海)有限公司 2016-12-07发布 2017-10-13截止
  • 学历要求: 硕士
  • 英语要求: 精通
  • 年龄要求: 不限
  • 专业要求: 不限
  • 工作年限: 三年以上
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 上海市长宁区
  • 职称要求: 不限
  • 招聘人数: 1人

职位描述

 Position Summary:
• The main work is to work out CFDA registration plan and to keep the product registration under the plan. The position also needs to maintain efficient and systemic communication with local commercial team cross functions and division to improve the registration process. Meanwhile the position needs to manage the regulations and regulatory files to be updated in time and conduct analysis with action plan.
 Detailed Job Descriptions:
• Work out CFDA Registration plan every year with fully communication with commercial team, as well as divisions.
• Conduct registration summary work Monthly or quarterly with root cause analysis and action plan;
• Management of Regulation/ regulatory environment monitoring and analysis with prospective action plan;
• Daily registration work supervise with solutions;
• Keep risk analysis of current sold products, and efficient report to upper management.
• Process improvement of registration.
• Keep efficient and systemic communication with division and local commercial team, as well as cross functional teams
• Lead global registration related project in China.
• Ensure the good communication with related authorities, as well as industrial associations.
 Qualifications:
• Bachelor degree or above in medical/biological/pharmaceutical majors; Master degree is preferential.
• 6-8 year work experience in medical device registration. IVD field is preferential.
• Being familiar with medical device registration process, complete product registration standards, registration documents preparation; More than 2 years working experience in medical device registration, and successfully registered products, management skills is preferential.
• Fluent English language skill, which is proficient to communicate with global RA Department in USA.

联系人: HR

地    址:上海市长宁区

Bio-Techne China(R&D Systems China)

Bio-Techne China Co.,Ltd. [安迪生物科技(上海)有限公司] 是由美国Bio-Techne Inc.在中国投资的外商独资企业,主要从事各种细胞因子及其相关产品的销售和技术上的服务、培训与咨询。公司产品涉及许多生命科学研究领域,如发育生物学、肿瘤研究、血液学、免疫学和神经科学等等。

我们致力于为中国生命科学研究领域的科学家们提供研究所需要的高品质产品,满足用户的需求,从而加速中国生物制药和生命医学市场的发展,提高疾病的诊断和治疗水平,以造福全人类。

Bio-Techne(R&D Systems)总公司于1976年成立于美国,在美国NASDAQ上市 ( ...详情

单位概况

安迪生物科技(上海)有限公司
近两周应聘简历处理率:20%
制药/生物工程
生物企业 其他
20~99人
上海市长宁区
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