Project Manager - Registration
北京安德医智科技有限公司
- 公司规模:150-500人
- 公司性质:合资
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2020-12-28
- 工作地点:北京
- 招聘人数:若干人
- 工作经验:无需经验
- 学历要求:硕士
- 职位月薪:2-2.5万/月
- 职位类别:项目经理
职位描述
Job Description
? Helping in patent preparation as well as other matters related to patents
- Work closely with different machine learning project teams to understand their technical solutions
- Work closely with Regulatory Affair department and technical departments to standardise and implement SOP such that it meets regulatory requirements
- Work closely with research engineers in translating their results into technical files for product registration
? Plan, develop, organize, write and edit technical files/ Manual SOP/ WI/ Forms to meet the quality standards (ISO13485:2016, FDA and CE)
? Work closely with team members to obtain an understanding of the products and solutions for documentation requirements
Job Requirement
? Minimum PhD and above in Engineering or Science
? Good scientific sense and experience in writing technical and research papers
- Good mathematical and statistical background
- Able to do coding for organising and analysing of statistical results
? Preferred bilingual in English and Mandarin
? Outstanding organization and communication skills with an excellent command of the English and Chinese language and the ability to clearly and concisely communicate in writing
? Competency in Microsoft Word, Excel and PowerPoint
Other skills:
? Collaborative work style, fostering cooperation and teamwork.
? Good verbal and written communications skills in English.
? Effective interpersonal, negotiation and conflict resolution skills.
公司介绍
安德医智科技有限公司总部设立在北京,并在新加坡、卢森堡成立了全资子公司。
旗下 BioMind 系列产品是目前全球取得认证最多、中国取得国际认证最早的医疗人工智能产品
已取得 NMPA 辅助诊断三类注册认证
已申请国内国际专利20余项,其中90%为发明专利,同时已取得19项软件著作权
美国 FDA 已受理
联系方式
- Email:hr@biomind.ai
- 公司地址:地址:span国家神经系统疾病临床医学研究中心