Regulatory Affairs Supervisor
施乐辉医用产品国际贸易(上海)有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2021-01-07
- 工作地点:上海-静安区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:本科
- 职位月薪:1.5-2千/月
- 职位类别:医疗器械注册
职位描述
Responsibilities:
This is very important position to SPM product registration in China. Under that position, the staff needs to:
1. Set up the registration plan for SPM products according to marketing launch plan or expiration date of original certificate, keep good communication with supervisor and co-worker, provide monthly update for the projects (15%);
2. Follow up testing and technical review for the registration ( 30%)
3. Cooperate with local marketing and sourcing company, push the whole registration process going forward as planed following the SOP requirement. ( 20 %)
4. Set up good relationship with authority from testing centre and technical evaluation centre. (10 %)
5. Assist SPM RA manager to proceed initial and renewal registration in China according to the plan to support SPM business growth in China(10%)
6. Keep good documentation management for the registered products. ( 5%)
7. Provide the regulatory support to other departments in daily work ( 5%)
8. Lead RA project and make sure it’s completed as planning ( 5%)
Location: Beijing commercial
Education: Batchlor and above
Experience: 3 years+ registration experience
Competences: knowledge and experience on medical device registration, Resilence, Agile, communication skill, interpersonal effectiveness, result driven, look into detail, custom focus etc
Physical Demands: Medical or biological background, come from science department in a college is preferred.
English communication ability, read,write and speak fluently Team work spirits
职能类别:医疗器械注册
公司介绍
We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
? Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
? Advanced Wound Management - wound care treatment and prevention products used to treat hard to heal wounds
? Sports Medicine - minimally invasive surgery of the joint
? Trauma & Extremities - products that help repair broken bones
We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion.
We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .
联系方式
- Email:Dora.Cui@smith-nephew.comAble
- 公司地址:北京市东城区东中街9号东环广场A座二层B-E号