注册专员-医疗器械
上海外服(集团)有限公司
- 公司规模:1000-5000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:2019-04-10
- 工作地点:北京-朝阳区
- 招聘人数:若干人
- 工作经验:无工作经验
- 学历要求:本科
- 职位月薪:1-1.5万/月
- 职位类别:医疗器械注册
职位描述
Summary of Job Responsibilities: 1. Drive RA compliance excellence to meet internal process requirements and external legislation. 2. Drive Labelling E2E compliance excellence 3. Represent RA and provide LOC RA input to corresponding quality functions and project teams 4. Build RA quality culture
Dimensions of Job: 1. Regulatory compliance support for Quality Management System building 2. Labelling End to End labelling process optimization and operation excellence to support new product launch acceleration and marketed products compliance 3. Regulatory process development & resource planning
Principal Accountabilities of Job: 1. Regulatory compliance oversight and support for Quality Management System building, including development of RA compliance plan and quality metric, and contribution to quality system of Business quality, R&D quality, Site quality and others 2. Drive internal regulatory process development to reflect internal process and external legislation change, including labelling E2E process optimization, to reflect regulatory environment change, business model changes, and to mitigate identified gaps. 3. Driving system compliance and data accuracy, including new system launch readiness. 4. Leading China RA record Management, to ensure timely record archiving and retention, to support product LCM 5. Credo based behavior with regulatory compliance excellence
Key Performance Measures: 1. RA quality metrics are well defined and implemented 2. Labelling process high efficiency and AW high quality 3. No critical finding 4. Cross-team connection and leadership
Qualifications & Competencies: 1. A bachelor degree major in chemistry, pharmaceutics, biology or a related life-science discipline. A master degree or above is preferable. 2. Minimum of 2 years’ experience in a multinational pharmaceutical company, relevant compliance management working experiences is preferable. 3. Strong oral & written communication skill; good leadership capability and ability to work under pressure. Demonstrated ability to effectively manage. 4. Have knowledge of regulations and guidelines, esp. labelling 5. Proficiency in verbal and written English; good computer skill, good presentation skill.
职能类别: 医疗器械注册
公司介绍
联系方式
- Email:hr29@fsg.com.cn
- 公司地址:梅园路77号上海人才大厦24楼 (邮编:200070)
- 电话:17612110548