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10年以上经验 -
本科 -
招若干人 -
11-09 发布
职位描述
职位描述： Key Responsibilities:SME (subject matter expert) of medical device (md)/in vitro diagnostic (IVD) , especially IVD antibodies, lead a group to provide regulatory support to company IFE science business. include but not limitedwork with global team and/or local agency to prepare regulatory submission documents for MD/IVD products, implement md/IVD products registration/renew/supplementary application. manage the registration project progress, make sure to meet the time line. responsible for post-market regulatory compliancemonitor MD/IVD related regulation changes, evaluate the impact, provide regulatory guidance in risk assessment and recommendations to mitigate potential riskactively communicate with business, marketing team, provide regulatory consultancy and regulatory strategy for MD/IVD projectwork as effective interface between company and authority/industry associationresponsible for company life science animal by-products (ABP), biologics special products and hard wares importation regulatory compliancecoordinate related function departments to drive, manage the ABP and biologics products’ compliance importationlead a group to prepare documents for import permit application, submit and follow up application process with local authority, make sure get import permit approval per plankeep good connection with local authorities (AQSIQ, local CIQ), monitor relevant regulation changes, timely inform internal stakeholders about regulations with impact to businessprovide regulatory consultancy and strategy for new biological material importation projectresponsible for coordinate with global team to ensure 3c compliance or out of scope license registrationresponsible for coordinate with global team to ensure energy label compliance or out of scope license registrationKey Requirements:technical degree required, biopharmaceutical, bioscience related science and/or engineering discipline > 6 years experiencefluent in Chinese native & English (verbal and written) is requiredexperience of minimum six years in MD/IVD regulatory affairs, extensive knowledge of china regulations in MD/IVD, especially familiar with IVD antibodiesfamiliar with regulations of ABP and biological material importation is a plusexperience working in a global, matrix environmentexcellent interpersonal, presentation, listening and communication skillsstrong organizational and time management skillsability to manage multiple priorities and deliver accurate outcomesability to indirectly influence other organizations and culturesability to work in multi-cultural teams and strong people leadership 职能类别： 医疗器械注册 药品注册
联系方式
北京
公司信息
华德士于1985年在英国伦敦成立，是全球领先的国际专业人才招聘咨询顾问公司。华德士网络覆盖全球五大洲，在24个国家拥有分公司。华德士（中国）目前在上海，北京和苏州设立分公司；全国员工达到150人左右，为客户提供长期雇员招聘咨询服务。国内的业务主要集中在会计与财务、银行与金融服务、人力资源、综合管理、信息技术、销售与市场、供应链、采购以及物流等岗位。华德士的目标是与客户和候选人建立长期可信赖的战略伙伴关系，为他们提供最高品质的服务。
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