Assis RA Manager_Medical Device

职位描述


1. Principal Duties and Responsibilities (General Summary ,essential functions and authorities, etc.)
主要工作职责(基本概况,主要功能,权限等)
 Product registration related including new and renewal
o Handling registration process, including
 document requirement
 dossier prepare
 submit to CFDA
 follow up evaluation procedure
 sample ordering, type testing
 solve various problems in whole process
 file dossiers with consistent requirement
o Ensure to obtain the regulatory permits on time, in support of the organization's business requirements
o Having a good and consistent communication with local marketing and known well the business plan especially product launch plan
o Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration
o Paying attention to the market information such as the competitors’ with the analysis
 To coordinate the post market surveillance project
 Supporting Chinese IFU /labeling, copy review for product related
 Being involving into team working such as department meeting logistic arrangement
 Maintain & Input database like: RA database, RTL…
 Providing monthly report & analysis including latest registration status & post market surveillance
 Develop Regulatory Strategy and Plan for Chartered R&D Initiatives from Sourcing Companies and Partner with the project team to ensure the approval at each review gate.



资历
2. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
基本任职资格(包括教育背景和/或知识和/或培训和/或相关工作经验)
 Medical or related education background and knowledge
 6~8 years experience in Regulatory Affairs

3. Skill Sets and/or Training and/or Certification for the Special Position
特殊岗位的技能和/或培训和/或证书要求
- Good communication skill
- Good time management
- Well computer operating
- Better English and Chinese in writing and oral


主要地点
中国-北京-北京-
组织
强生(上海)医疗器材有限公司
工作
Regulatory Affairs
Requisition ID
1905773121W