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

Job Description

任务/职位简述 Mission/Position Headline:
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.

3 years domestic IVD registration experience, preferred experience with R&D, clinical trial, quality system, CE or FDA.

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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