医疗器材注册专员(RA Specialist)
中智上海经济技术合作公司
- 公司规模:500-1000人
- 公司性质:国企
- 公司行业:专业服务(咨询、人力资源、财会)
职位信息
- 发布日期:2015-01-28
- 工作地点:北京
- 招聘人数:若干
- 工作经验:5-7年
- 学历要求:本科
- 语言要求:英语良好
- 职位月薪:面议
- 职位类别:药品注册
职位描述
要 求:
1.Bachelor degree or above, major in pharmacy or the relevant;
2.At least 5 years of experience in Medical Device industry;
3.Excellent knowledge and competency in Medical Device registration.
4.Rich experience in class III sterilized disposable products
5.Good relationship with SFDA and the affiliates of medical device relevant;
6.Good communication skill, creative thinking, with teamwork spirit;
7.Good written & spoken English + Mandarin; and Good computer skill;
8.Excellent interpersonal skills and ability to work effectively with multiple functions
9.Result and detailed oriented and able to work under pressure to meet tight timelines.
职 责:
The RA Specialist in this newly-established position will report to the Regulatory Affairs Manager, based in Beijing and provides regulatory support on Medical Device regulatory requirements in line with corporate and divisional objectives.
Being the RA Specialist for Renal Device, the professional in this position will fulfill regulatory responsibilities including but not limited to the following:
Establish a thorough submission plan for each assignment within the timeline agreed by stakeholders;
Provide regulatory strategic input for product development program to drive rapid product registration approvals.
Obtain and maintain the necessary licenses, including timely approval of major variation applications (“MVAs”), minor variation applications (“MIVs”), and all other necessary approvals for any variation in the Renal medical device with the regulatory/legal compliance manner.
Liaising with the relevant governmental bodies and regulatory authorities
1.Bachelor degree or above, major in pharmacy or the relevant;
2.At least 5 years of experience in Medical Device industry;
3.Excellent knowledge and competency in Medical Device registration.
4.Rich experience in class III sterilized disposable products
5.Good relationship with SFDA and the affiliates of medical device relevant;
6.Good communication skill, creative thinking, with teamwork spirit;
7.Good written & spoken English + Mandarin; and Good computer skill;
8.Excellent interpersonal skills and ability to work effectively with multiple functions
9.Result and detailed oriented and able to work under pressure to meet tight timelines.
职 责:
The RA Specialist in this newly-established position will report to the Regulatory Affairs Manager, based in Beijing and provides regulatory support on Medical Device regulatory requirements in line with corporate and divisional objectives.
Being the RA Specialist for Renal Device, the professional in this position will fulfill regulatory responsibilities including but not limited to the following:
Establish a thorough submission plan for each assignment within the timeline agreed by stakeholders;
Provide regulatory strategic input for product development program to drive rapid product registration approvals.
Obtain and maintain the necessary licenses, including timely approval of major variation applications (“MVAs”), minor variation applications (“MIVs”), and all other necessary approvals for any variation in the Renal medical device with the regulatory/legal compliance manner.
Liaising with the relevant governmental bodies and regulatory authorities
公司介绍
中智上海经济技术合作有限公司(简称中智上海公司)是中智全国性服务网络战略布局中重要的战略成员。目前,中智上海公司服务2万余家客户企业,雇员数达77万。公司主营业务包含:人力资源外包、招聘+业务外包、国际业务、培训业务和贸易服务五大板块。2013年,中智上海公司荣获由上海市政府颁发的“上海市质量金奖”。2016年,公司荣获由国家质检总局颁发的第二届“中国质量奖”提名奖。2018年,中智上海公司第一批获得由上海品牌国际认证联盟颁发的“上海品牌”荣誉。中智上海公司秉承“诚信、尊重、公正、专业”的服务精神,积极践行社会责任,不断追求卓越,持续为客户和雇员创造价值。
应聘者请发简历至 resume@ciicsh.com
应聘者请发简历至 resume@ciicsh.com
联系方式
- Email:resume@ciicsh.com
- 公司地址:地址:span上海