RA specialist II Project
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Job Location:
Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
主要职责/Key Responsibilities
1. 根据注册目标执行IVDR 注册计划及时跟踪IVDR 注册工作的进展确保注册目
标完成
2. 作为RA 代表参与公司新产品开发项目输入法规策略并持续跟进项目确保产
品注册目标完成
3. 协调完成国内及国际临床相关事宜
4. 协助完成国内新产品注册递交及延续变更事宜
5. 收集体外诊断试剂相关国家法规和标准的要求并跟踪其发展动态组织相关人员及
时在公司内部转化并贯彻实施如有必要则组织相关培训以确保公司的产品符合
法规标准的要求
6. 收集国家盘的更新并协调完成国家盘的更新工作
7. 协助上级制定团队目标并指导团队成员的业务开展
8. 完成其他上级交办的工作任务
任职资格/Job Requirements
1. 资格证书/Certificate
没有资格证书要求有项目管理资格认证证书优先
2. 外语技能/Foreign Language Skills
英语读写良好及良好的英语听说能力
3. 计算机软件技能Software Skills
能熟练的操作OFFICE 软件
4. 工作经验或专业背景/Work Experience or Professional Background
1 年以上药品或医疗器械注册或临床管理工作经验有医院临床实践经验者优先
5. 教育背景/Education Background
大学本科及以上医药生物临床医学等相关专业背景优先
6. 其它要求/Others
较强的分析和评估能力较强的判断力和解决问题的能力良好的沟通协调和抗
压能力;快速反应高执行力同时具有主动性和灵活性
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ID Infectious Disease
LOCATION:
China > Hangzhou : #198 12th Street Hangzhou Economic & Technological Development Area
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
IC
Key Skills
- Information Management
- Entertainment
- ABAP
- Corporate Risk Management
- Information Technology Sales
- Clinical
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
