职位描述
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职位职能:
??医疗器械注册??生物工程/生物制药
职位描述:
JOB TITLE: Regulatory Affairs Specialist--Beijing
PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
1. Responsible for documentation preparation of product registration; Ensure the document compliant with relevant regulation requirements in China
2. Responsible for coordination of each function’s activities to finish product registration according to China regulation
3. Responsible for liaison with the Chinese regulatory authorities
4. Response for collects related update regulation information
5. Implement the registration Clinical Trial to ensure the correct direction via the selection of predicate in China
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
1. Minimum 3 years of medical device product registration experience, IVD is preferred
2. Familiar with BMC portfolio, and know the resource both technical and guanxi.
3. Good interpersonal and communication skills, team player and taking ownership
4. Able to work under pressure and fast response
Education & Knowledge:
1. Bachelor’s Degree or above in clinical medicine, biology & pharmacy or related major.
2. Basic English skill of reading and writing
职位名称：注册事务专家
1．首要工作任务和总体工作目标
根据技术资料起草产品注册标准，确保其符合中国SFDA的相关法律规定。
1. 协调相关部门，按照计划完成产品的注册；
2. 负责和药监局官员保持良好的沟通和联络；
3. 负责收集相关规章制度的实时信息。
4. 负责产品注册所需的相关临床试验注工作
5. 跟踪医疗器械法规变化情况；根据法规向管理层提供相应产品的注册建议；
6. 跟踪产品注册和审评进程；
学历和经验要求
工作经验和个人能力：
1. 从事医疗器械产品注册工作3年以上的工作经验，所涉领域为体外诊断器材者优先。
2. 熟悉BMC portfolio, 对注册相关的技术和人脉关系都有所掌握
3. 良好的人际关系，沟通能力，良好团队协作和高度的责任感
4. 能够承受工作压力并作出快速反应。
教育和知识要求：
1. 拥有临床医学、生物学、药学或相关专业的本科及以上学历。
2. 良好的英语读写能力。
