RA Specialist
北京鑫源恒信医疗器械有限公司
- 公司规模：少于50人
- 公司性质：合资(非欧美)
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2012-08-31
- 工作地点：北京-朝阳区
- 招聘人数：1
- 工作经验：一年以上
- 学历要求：本科
- 语言要求：英语精通
- 职位类别：医疗器械注册
职位描述
Position Summary:
- Communicate with product manager to confirm the product name, model and code.
- Fill out the request form and send them to SFDA
- Collect necessary documents, compile product standard.
- Select typical samples, get the final confirmation from product manager, then place the sample order for local testing.
- Follow the inspection with the engineer of Inspection Center, contact with manufacturer and get the feedback timely.
- Solve all the problem happened during the testing procedure independently, and get the qualified test report as soon as possible.
-During the reviewing procedure of SFDA, resolve all the problems concerning product standard or testing report. Ensure to get final approval timely.
- Learn the related regulation and technical knowledge.
- Improve English and communicate skill with manufacturer smoothly.
Principal Accountabilities:
- Familiar with MD registration regulation.
- Good communication with foreign manufacture concerning registration issue.
- Can arrange registration documents independently.
- Can compile the product standard independently.
- Can follow up type testing independently.
- Submit the registration documents to SFDA timely.
- Can resolve problems during the reviewing of SFDA.
Experience:
- 1-2 years experience of MD registration.
- Handle imported MD registration independently.
- Good command of English in listening, speaking, reading and writing.
- To be honest, patient and diligent.
Education:
- Bachelor degree, major in English, got the ceritficate of TEM-8.
- or major in medical, pharmaceutical or related.
- Communicate with product manager to confirm the product name, model and code.
- Fill out the request form and send them to SFDA
- Collect necessary documents, compile product standard.
- Select typical samples, get the final confirmation from product manager, then place the sample order for local testing.
- Follow the inspection with the engineer of Inspection Center, contact with manufacturer and get the feedback timely.
- Solve all the problem happened during the testing procedure independently, and get the qualified test report as soon as possible.
-During the reviewing procedure of SFDA, resolve all the problems concerning product standard or testing report. Ensure to get final approval timely.
- Learn the related regulation and technical knowledge.
- Improve English and communicate skill with manufacturer smoothly.
Principal Accountabilities:
- Familiar with MD registration regulation.
- Good communication with foreign manufacture concerning registration issue.
- Can arrange registration documents independently.
- Can compile the product standard independently.
- Can follow up type testing independently.
- Submit the registration documents to SFDA timely.
- Can resolve problems during the reviewing of SFDA.
Experience:
- 1-2 years experience of MD registration.
- Handle imported MD registration independently.
- Good command of English in listening, speaking, reading and writing.
- To be honest, patient and diligent.
Education:
- Bachelor degree, major in English, got the ceritficate of TEM-8.
- or major in medical, pharmaceutical or related.
公司介绍
北京鑫源恒信医疗器械有限公司为中外合资生产企业, 专业生产预防龋齿的氟化泡沫、氟保护漆等系列产品，并向中国口腔行业引进世界先进的口腔预防保健材料，如美国PULPDENT脱敏剂、德国VOCO窝沟封闭剂、美国KERR、美国SybronEndo等众多国际品牌产品。本公司销售网络覆盖全国医疗单位、妇幼保健机构及学校卫生系统，利用牙防专家技术讲座及技术交流活动，积极宣传口腔保健知识，致力于提高全民口腔保健意识，在广大用户中树立了良好的信誉，在促进青少年儿童口腔预防保健的行业中成为最具有影响力的口腔专业产品公司。
本企业通过了ISO9001国际质量管理体系及YY/T0287-2003医疗器械质量管理体系认证，具备完整的生产销售质量管理体系，随时准备与国内外有识之士携手共进，共同促进中国口腔预防保健事业的创新与发展。
本企业通过了ISO9001国际质量管理体系及YY/T0287-2003医疗器械质量管理体系认证，具备完整的生产销售质量管理体系，随时准备与国内外有识之士携手共进，共同促进中国口腔预防保健事业的创新与发展。
联系方式
- 公司网站：http://www.jykqw.com