职位详情
RA supervisor(medical device)(16薪) 25-30K/月
上海-徐汇区 本科 5-10年 全职3人
英语 熟练
2023-04-18 更新
福利待遇
五险 公积金 带薪年假 周末双休 年终奖
职位描述
一、Job description 1)Responsible for regulatory activities for all medical device products within China. 2)Ensure the registration and regulatory compliance of Reckitt marketed products with relevant national regulatory requirements to bring competitive advantage to our brands. 3)Leading on the preparation, maintenance and update of product registration/license and regulatory compliance files. 4)Leading on the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation applications and negotiating with governmental authorities to obtain rapid approvals. 5)Developing and maintaining a database of local regulatory requirements. 6)Providing regulatory and product compliance expertise in medical device area of advertising, label claims and printed materials for existing and new products. 7)Regular updates on latest regulatory affairs development in China and provide insights on compliance matters on medical device related regulatory affairs. 8)Interfacing with local government agencies and industry associations to assess the impact and implementation of required company compliance with all medical device related regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products. 9)Representing Company interests with local government agencies, industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines that do not impose excessive or unfair burdens on ourf industry or products. 二、Requirement 1)Education: Bachelor degree and above, major in medicine, chemistry, biology or other related major; 2)Work experience: 5-8 years and above working experience in medical device regulations, familiar with relevant laws and regulations of industry; end to end regulatory project experience, medical device product experience is preferred; 3)Strong communication and coordination ability and sense of responsibility, good team spirit; 4)Language and skills: good English listening, speaking, reading and writing; Proficient in office software; 5)Core quality: responsible & reliable, detail oriented, able to work under pressure.
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