北京招聘

Report To: CEO
Department: RA
Location: Beijing

Job Objective:
The RA Manager will be in charge of developing strategies to ensure that the product distribution and sales are in compliant with Chinese laws and regulations. He or she will develop and execute plans to seek CFDA approvals of products, including instruments and reagents, for medical applications.

Major Responsibilities:
1. Plan and execute effectively the registration of medical devices and IVD reagents.
2. Prepare dossiers for submission to CFDA.
3. Track the whole process and solve various problems timely.
4. Ensure to obtain the regulatory permits on time.
5. Establish good communication with approval agency and experts.

Requirements:
1. Bachelor degree or above, major in biomedical or related.
2. At least 3 years of experience in biomedical industry.
3. Excellent knowledge and competency in medical device and IVD reagent registration and relevant technical guidelines.
4. Good relationship with the approval agency.
5. Good communication skill, creative thinking, with teamwork spirit.
6. Result and detailed oriented and able to work under pressure to meet tight timelines.
7. Fluent oral and written English.
8. Good Computer skill.

    北京贝瑞和康生物技术有限公司（以下简称贝瑞和康）成立于2010年5月，是致力于应用高通量基因测序技术，为临床医学疾病筛查和诊断提供“无创式”整体解决方案的研发型生物科技公司。先后于2011年9月获得中关村高新技术企业认证，2012年12月获得国家高新技术企业认证。