RA工程师
10000-20000元
应届毕业生
本科
职位描述
工作职责Responsibilities:
1、负责医疗器械国际市场准入和注册工作;
To undertake the medical device registration works in International area;
2、负责相关区域的医疗器械法规的研究分析和导入、产品注册资料的编写、收集、递交;
To undertake the analysis and implementation of related regulations and technical standards of medical devices; writing, collecting and submitting the registration dossier;
3、负责医疗器械注册过程中与注册顾问及相关监管机构的联络沟通;解决注册问题,推进注册进程、保证良好注册结果;
To maintain active communication with consultants, and relating authorities; solving registration problems, pushing forward the registration process and guarantee a favorable registration result。
职位要求Job Requirements:
1、电子、自动化类理工科专业背景,生物医学工程专业优先;
Major in electronics, automation engineering and biomedical engineering will be preferable;
2、有医疗行业法规注册相关工作经验优先(一类二类三类都可以);
Working experience in medical device registration will be preferable;
3、具备良好的沟通合作的能力和团队合作精神,抗压能力强;
Excellent communication skills with team work spirit; ability to maintain good performance under pressure;
4、良好的英语读写能力;
Good communication skill includes English in reading/writing and oral。
1、负责医疗器械国际市场准入和注册工作;
To undertake the medical device registration works in International area;
2、负责相关区域的医疗器械法规的研究分析和导入、产品注册资料的编写、收集、递交;
To undertake the analysis and implementation of related regulations and technical standards of medical devices; writing, collecting and submitting the registration dossier;
3、负责医疗器械注册过程中与注册顾问及相关监管机构的联络沟通;解决注册问题,推进注册进程、保证良好注册结果;
To maintain active communication with consultants, and relating authorities; solving registration problems, pushing forward the registration process and guarantee a favorable registration result。
职位要求Job Requirements:
1、电子、自动化类理工科专业背景,生物医学工程专业优先;
Major in electronics, automation engineering and biomedical engineering will be preferable;
2、有医疗行业法规注册相关工作经验优先(一类二类三类都可以);
Working experience in medical device registration will be preferable;
3、具备良好的沟通合作的能力和团队合作精神,抗压能力强;
Excellent communication skills with team work spirit; ability to maintain good performance under pressure;
4、良好的英语读写能力;
Good communication skill includes English in reading/writing and oral。
联系方式
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