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SHDM 法规事务专员 RA Specialist(Pudong Zhoupu)

Job Description

任务/职位简述 Mission/Position Headline:
执行产品注册任务并为业务单元和当地项目团队提供产品注册的法规指导。
Implement product registration activities and provide regulatory guidance on product registration to both BU and local project team. 

职责领域 Areas of Responsibilities::
• 执行产品注册计划,并报告注册进度或技术问题,以使相关部门提前了解情况。
Implement product registration plan and report registration progress or technical concern to representative departments for earlier aware the situation.
• 与全球和当地监管部门以及其他部门密切合作,为所需文件提供建议,准备注册资料提交,并负责注册检测。
Work closely with global and local regulatory affairs and other department to advise required documents and prepare regulatory submission professionally, responsible for type testing.
• 与地方当局联络,及时向当局提供所有必要的注册材料,并与当局跟进,以确保产品快速、及时获得批准。
Work as liaison to local authority, timely deliver all necessary registration materials to authorities and follow up with authority to ensure rapid and timely approval of the product.
• 进行内部变更申请的法规影响评估。
Assess regulatory impact for internal change request.
• 保管所有注册相关文件、证书、报告等。
Keep all registration related documents, certificates, reports etc.
• 收集相关法规和标准信息,随时更新当地趋势和政策。
Collect related regulation and standard information, keep update on local trend and policy.
• 公司分配的其他工作。
Other tasks assigned by the company.

经验Experience
3年国内/国外体外诊断试剂注册经验,有研发、临床管理、质量体系、CE或FDA经验者优先。
3 years domestic IVD registration experience, preferred experience with R&D, clinical trial, quality system, CE or FDA.

教育Education
药学,生物,医学,检验,法规或其他相关专业的本科及以上学历。
Bachelor degree or above, major in pharmacy, biology, medicine, laboratory, regulation or related.





Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Early Professional

Job Type: Full-time

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