长沙 [切换城市] 长沙招聘长沙生物/制药/医疗器械招聘长沙药品生产/质量管理招聘

Regulatory Affairs Supervisor

康乐保(中国)医疗用品有限公司

  • 公司规模:10000人以上
  • 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:2013-05-13
  • 工作地点:珠海
  • 招聘人数:1
  • 工作经验:五年以上
  • 学历要求:本科
  • 职位类别:医疗器械注册  药品生产/质量管理

职位描述

Purpose of the job
Be in charge of quality control and domestic product registration related tasks in Zhuhai as well as supporting RA manager with other RA tasks

Responsibilities
1. Being in charge of quality control related tasks at Zhuhai warehouse
Key Activities:
- On site quality check for damage and for discrepancies between goods and invoices including label, IFU and package etc. Enter data into a database or other internal system to maintain up-to-date quality check records.
- Perform other routine quality control activities according to the company established procedures. For instance, maintain and update labels and IFUs in the system.
- Monitor warehouse activities to ensure that goods are stored correctly and safely in order to fulfil the requirements by FDA. Co-ordinate with relevant authorities when being inspected.
- Follow up each inconsistent case with relevant internal and external parties until it is solved and make the necessary claims.
- Responsible for qualifying new suppliers (incl. internal suppliers & OEM) to ensure they meet the required regulatory requirements (incl. IFU, label and product certificates etc.) upon Chinese standards.
- Provide necessary 'quality check & control' training for warehouse staffs.
2. Prompt follow-up and co-ordinate with internal relevant parties on regulatory matters.
3. Maintain good cooperation with external parties, esp. testing center, FDA and vendors to ensure ongoing cases completed on time.
4. Assist RA manager and department head with spontaneous cases as well as providing necessary assistance to colleagues with relevant requirements from time to time.

Required Skills and Qualifications
1. University graduated with relevant technical background
2. At least 5 years relevant working experiences.
3. Fluent English (read & written)
4. Adequate computer abilities
5. Self-motivated with strong accountability
6. Team spirits with good interpersonal communication skills
7. Desire to learn and eager to take challenges

公司介绍

康乐保集团.简介

康乐保公司是一家从事医疗护理用品开发、生产、销售和客户服务的企业,是全球领先的贴心护理产品和服务供应商。1957年成立于丹麦,1983年在哥本哈根证券交易所上市。产品领域涵盖了造口护理,泌尿和失禁护理,伤口和皮肤护理三大系列。60多年来,康乐保一直秉承对护理事业的热情和对有贴心护理需求的人们的关爱之心,用心倾听客户需求,致力于不断开发和投放自己的创新产品,让有贴心护理需求的人们生活得更轻松。

康乐保是欧洲财富500强企业之一,生产基地遍及全球,包括丹麦总部、匈牙利、美国、中国和法国。并在全球55个国家设有分支机构,目前全球雇员超过11000人。

康乐保(中国).简介

康乐保集团于2007年在北京投资注册成立了康乐保(中国)医疗用品有限公司,专注于在中国的销售、市场和客户服务。并在北京、上海、广州、武汉、沈阳设立了大区办事处。至今,在全国拥有员700多人,是一家快速成长和蓬勃发展中的公司。

目前,康乐保公司在中国市场销售的主要产品有造口护理、伤口护理和失禁护理三大系列产品。

联系方式

  • 公司地址:北京市朝阳区东方金融中心13层 (邮编:100020)
  • 电话:18614094197