Regulatory Affairs Specialist/ Senior RA Specialis
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:2020-03-16
- 工作地点:北京-东城区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:0.8-1.2万/月
- 职位类别:其他
职位描述
Role Overview:
1. Responsible for setting up the product registration plan per marketing’s registration request and NPD project plan 2. Responsible for registration of CFC NPD product according to the timeframe of registration plan
3. Responsible for following up type testing, preparing submission documents, communicating with NMPA authority during technical evaluation period, conducting in compliance with local regulatory agency requirements and relevant SOP.
4. Responsible for good documentation management.
5. Responsible for providing regulatory support to relevant department
6. Responsible for establishment of good working relationship with regulatory agencies and GBU supporting team Please include specific internal and external relationships, product focus (if any), regulatory requirements, etc.
Responsibilities: (Please specify % amount against each responsibility) This is the new RA position to support CFC business on NPD project and legacy products in BDA, that position needs to:
1. Set up the registration plan for CFC 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. ( 15 %)
4. Set up good relationship with authority from testing centre and technical evaluation centre. (15 %)
5. Provide regulatory support to BDA facility, business unit, as well as other function team for all the product responsible.(10%)
6. Keep good documentation management for the registered products. ( 5%)
7. Lead RA project and make sure it’s completed as planning ( 5%)
8. Compliance to company policy(5%) Location: Beijing commercial Education: Bachelor and above Licenses/ Certifications: Experience: 5 years+ registration experience Competences: Look into detail, custom focus, agile, resilience, result driven, good communication skill Physical Demands: Medical or biological background, come from science department in a college is preferred. English communication ability, read and write fluently, simple spoken English at least Team work spirits Travel Requirements: 10–25% (Please delete as appropriate
职能类别:其他
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