(ID64726)RA Manager-SH (职位编号：64726) 上海

月薪： 4-5万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 定期体检

职位描述

职位描述： POSITION: RA ManagerLOCATION: Shanghai, China某外资医疗器械公司SUMMARYThe RA Manager will lead all aspects of the China Regulatory Affairs function. Participate in developing and executing regulatory strategies as well as preparing documentation for approval of new products and existing core products for the 3 business units in China. Participate in new product development teams by assessing regulatory requirements required in China to achieve rapid market clearances and approvals. Support and file for modifications to existing products such as manufacturing transfers, design changes, and materials for products registered in China. Ensure that advertising and promotional activities are compliant with appropriate regulations and guidance. Participate in maintaining a strong working relationship with CFDA and reviewers.ROLES AND RESPONSIBILITIESThis position includes the following essential roles and responsibilities. Other duties may be assigned consistent with current and emerging business priorities.? Participates in establishing regulatory strategy and plans that lead to new product submissions in support of CFDA registration approvals.? Develops documentation and files for submissions for new or core product in China.? Closely supervises and monitors testing performed at Chinese test labs in support of product submissions.? Assists in establishing regulatory strategy and plans to obtain the appropriate regulatory clearances/approvals for existing products in terms of modifications to manufacturing facilities, design changes, material changes, etc.? Effectively manage projects by establishing project timelines to assure effective resource management and to facilitate project review.? Maintain open communications with CFDA and its reviewers? Review product labeling to assure labeling for China is compliant? Manage registration renewals? Prepare, revise, review, and maintain procedures to harmonize global regulatory policies and processes with requirements in China.? Provides effective communication, Systagenix’s project teams regarding new China regulations, policies and initiatives that could impact products and processes of the 3 business units.? Assists with preparation for and participate in CFDA audits.QUALIFICATIONS, EDUCATION and/or EXPERIENCE? Equivalent of B.A. or B.S. degree is the minimum requirement? Minimum of 7 years’ experience as a Regulatory Affairs professional in the medical device industry and at least 3 years’ experience in filing for registration approvals in China? Experience with regulatory filings in China with favorable clearance and approval times? Demonstrated ability to be a team player? Demonstrated ability to manage multiple projects? Good written and verbal English communication skills.? Demonstrated analytical and strategic-thinking, problem solving skills? Demonstrated communication and interpersonal skills and the ability to communicate with individuals at all levels within an organization.? Demonstrated ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.? Experience with MS Office applications including Word, Excel, & Outlook 职能类别： 医疗器械注册 关键字： 医疗器械 注册

联系方式

上海

公司信息

任仕达集团(Randstad Group) 成立于1960年，是全球最大的综合性人力资源服务机构之一，总部位于荷兰阿姆斯特丹。在全球40多个国家和地区设有4700多个分支机构，每天为57万名求职者提供工作岗位。2011年，其全球营业额达到162亿欧元，位列全球财富500强。 任仕达自2005年进入中国市场，总部设在上海，在华北、华东、华南等地区成立了多个分支机构，服务网络覆盖全国100多个一、二线城市，向企业提供包括搜寻与甄选、灵活派遣以及人力资源解决方案在内的全方位人力资源服务。 作为一家充满活力的专业招聘机构，任仕达始终坚持以人为本，不断追求创新。我们寻找才智过人、诚实可靠、胸怀抱负的求职者，把他们推荐给最适合的企业，帮助他们获得最具吸引力的薪酬和工作机会。 无论您是想拓宽职场发展之路，或是寻找正确的职业发展方向，我们的招聘顾问都会随时为您提供服务。 有了我们的协助，美好职业志在必得。 想了解更多详情，请登录任仕达中国网站www.randstad.cn，或在新浪微博上@任仕达，与我们互动。 www.randstad.cn

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企业入驻日期： 2017-11-09

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