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RA_法规事务专员_北京 ID177558
9千-1万
人 · 本科 · 2年及以上工作经验 · 性别不限2025/01/09发布
专业培训弹性工作绩效奖金定期体检多元包容悠长假期全面薪酬

建国路77号华贸中心3座28层

公司信息
碧迪医疗器械(上海)有限公司

外资(欧美)/1000-5000人

该公司所有职位
职位描述
Responsible for Imported BDI_PI Products Regulatory Affairs
KEY RESPONSIBILITIES(主要职责)
- Maintain current NMPA approved certificates, including extension registration, change registration and support BU&RC to resolve post-marketing issues.
- Make charge of new products launch in China, including make strategy, control registration timeline, type test, prepare registration documents, following evaluation and get approval.
- Host regular meeting with WW to get requested documents and update registration status.
- Follow NMPA regulations and analysis impacts to BD or responsible products. Other affairs within the team.

SKILLS AND ABILITIES(技能)
- Medical/Pharmacy background, relevant experience on regulatory affairs
- Bachelor degree or above
- At least 2 years of regulatory affairs experience
- Proficient in spoken and written English and Chinese
- Ability to work independently and experience in a team on multiple projects Excellent interpersonal and communication skills

DESIRABLE(优先条件)
- Medical device company working experience
- Overseas education background

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