RA Specialist-法规专员（500强欧美医疗行业）
苏州泰思企业管理咨询有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-10-15
- 工作地点：苏州
- 招聘人数：1
- 工作经验：三年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：认证工程师/审核员
职位描述
Job requirements:
Domestic registration experience of Medical device products (Class I, II and III)
Excellent planning and organizational skills
Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
Teamwork and communication and presentation skills - listener, learner and thinker
Product awareness and GMP, ISO13485 quality system
Continuous and versatile learning ability
Thorough and flexible.
Cross culturally aware.
Global team player.
Enthusiastic and committed
Written and verbal English skill
Possess computer competency in Microsoft office software, data collection and general analysis tools
University degree or above
Job responsibilities:
Provide full support to the Regulator Affairs Manager - to ensure that all aspects of the registration program in China are conducted in accordance with the requirements of the company and the regulators.
Provide dedicated support to Franchises and RA representatives WW for the registration of the products manufactured by company.
Facilitate the product registration activities in China by compiling appropriate dossiers, submissions and responses to regulatory bodies. Ensures compliance with regulatory agency regulations and interpretations.
Provides solutions to a variety of problems of moderate scope of complexity.
Maintain processes for submissions, interim notifications and periodic re-submissions.
Maintain information on regulatory requirements and the status of product registrations. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Maintains and archives all regulatory documentation. Conducts searches of existing files for requested information.
Provide support and advice to worldwide company colleagues, concerning regulatory requirements in China.
Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process in China.
Domestic registration experience of Medical device products (Class I, II and III)
Excellent planning and organizational skills
Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
Teamwork and communication and presentation skills - listener, learner and thinker
Product awareness and GMP, ISO13485 quality system
Continuous and versatile learning ability
Thorough and flexible.
Cross culturally aware.
Global team player.
Enthusiastic and committed
Written and verbal English skill
Possess computer competency in Microsoft office software, data collection and general analysis tools
University degree or above
Job responsibilities:
Provide full support to the Regulator Affairs Manager - to ensure that all aspects of the registration program in China are conducted in accordance with the requirements of the company and the regulators.
Provide dedicated support to Franchises and RA representatives WW for the registration of the products manufactured by company.
Facilitate the product registration activities in China by compiling appropriate dossiers, submissions and responses to regulatory bodies. Ensures compliance with regulatory agency regulations and interpretations.
Provides solutions to a variety of problems of moderate scope of complexity.
Maintain processes for submissions, interim notifications and periodic re-submissions.
Maintain information on regulatory requirements and the status of product registrations. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Maintains and archives all regulatory documentation. Conducts searches of existing files for requested information.
Provide support and advice to worldwide company colleagues, concerning regulatory requirements in China.
Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process in China.
公司介绍
苏州泰思企业管理咨询有限公司 Tiger Services (Suzhou) Co., Ltd 位于苏州工业园区，这一当今中国最具经济活力的城市。我们为苏州，上海，北京，常州，无锡，深圳，山东，成都等城市的企业提供专业人才的搜索和服务。
我们拥有丰富和独特的资源，确保我们能为客户迅捷、准确的提供合适的人才招聘服务。
我们同时致力于为人才提供最全面的讯息，以帮助人才进入一个良好的企业环境，拥有一个良好的职业发展的天地。与此同时，我们也为人才提供职业发展和职业目标制定的专业咨询。
我们的使命是，在为企业提供正确的人才时，帮助人才进入一个有益于个人职业发展的环境。
我们深信，我们的成功基于人才的发展和企业的成功。我们深信，我们用心的服务创造增值的价值。
公司网址：泰思.中国 or www.tigerservices.cn
公司邮箱：recruitment_ts@vip.163.com或hr@tigerservices.cn或olive.wu@tigerservices.cn
传真：400-6981-163 分机号：23070
我们拥有丰富和独特的资源，确保我们能为客户迅捷、准确的提供合适的人才招聘服务。
我们同时致力于为人才提供最全面的讯息，以帮助人才进入一个良好的企业环境，拥有一个良好的职业发展的天地。与此同时，我们也为人才提供职业发展和职业目标制定的专业咨询。
我们的使命是，在为企业提供正确的人才时，帮助人才进入一个有益于个人职业发展的环境。
我们深信，我们的成功基于人才的发展和企业的成功。我们深信，我们用心的服务创造增值的价值。
公司网址：泰思.中国 or www.tigerservices.cn
公司邮箱：recruitment_ts@vip.163.com或hr@tigerservices.cn或olive.wu@tigerservices.cn
传真：400-6981-163 分机号：23070
联系方式
- Email：ts@vip.163.com
- 公司地址：上班地址：江苏-常州