医药人才网 > 全国店长招聘 > 江苏省生物制药/医疗器械招聘 > 强生(苏州)医疗器材有限公司招聘 > 更多质量法规事务专员 Regulatory Affairs Specialist招聘

质量法规事务专员 Regulatory Affairs Specialist [ 投诉职位 ]

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基本信息

工作地点：苏州市
年龄要求：20~45岁
要求学历：不限
招聘人数：1人
工作经验：2年以上
专业要求：不限

任职要求/岗位职责

备注：此职位签订第三方合同，介意者勿投。
Title/职位: Regulatory Affairs Specialist
Department/部门: QS-RA
Location/地点: Suzhou, Jiangsu Province, P.R.China
Reports to/汇报对象: Regulatory Affairs Supervisor Key Responsibilities
-Provide full support to the Regulator Affairs Supervisor -to ensure that all aspects of the registration programme 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 Johnson & Johnson Medical (Suzhou) Ltd.
-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.
Qualifications
-有产品注册经验者优先
-University degree or above
-2 years above working experience of some aspects of Regulatory affairs in a medical device, pharmaceutical or similar regulated industry
-Working experience in an international group (desirable)
-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

企业介绍

强生(苏州)医疗器材有限公司

美国强生公司成立于1886年，是目前世界上规模、产品种类多的医疗保健公司之一。公司的主要业务分为3部分，即医疗和诊断器械、日用消费品及药品。强生公司在57个国家拥有200多家分公司，全球员工总数超过11万，2005年在全世界170多个国家和地区市场的销售收入达到505亿美元，其中医疗和诊断器械业务所占比例近40％。作为一家拥有百年悠久历史的企业，强生公司长期以来一直保持着高速的增长发展势头，跻身世界500强企业排名超过半个世纪，并多次被《财富》杂志等媒体评为“受赞赏公司”、“雇主”。

自1943年首次发布企业信条起，强生公司一直在全球业务范围和经营活动中坚持履行贯彻其信条，将信条作为公司的价值理念和一切工作的指导原则。简单概括起来，强生公司的信条就是如下四点：

·对顾客负责

·对员工负责

·对社会负责

·对股东负责

每一名员工自加入公司起就随时铭记该信条，对信条的坚持时时刻刻贯穿融入到了公司工作的每一个环节和方面。强生公司之所以能在过去的漫长岁月中不断取得如此大的成就和发展，很大程度上就归功于对信条的贯彻执行。在医疗和诊断器械领域，强生公司雄踞全球的领导者地位，在其全部产品种类中，有超过70％的产品占有的市场份额排名在世界或第二。目前在该领域，强生公司共有10大类主要品牌和产品。

强生公司一直非常关注飞速发展的中国经济和中国市场。早在改革开放之初的1982年，强生公司就在北京成立了个代表处。1985年，强生在西安开办了其在中国大陆的家企业－西安杨森制药有限公司。随后，强生在中国大陆投资创办了一系列合资或独资企业，包括强生（中国）医疗器材有限公司、上海强生制药有限公司、强生（中国）有限公司等。基于在中国投资项目的成功以及对未来中国经济和市场发展的良好预期，促使强生公司决定进一步扩大在华投资规模。为了有效满足亚太和中国市场的需求及降低成本，强生公司决定在中国苏州新建一个医疗和诊断器械生产园区，将相当数量的产品转移至中国生产并供应全球市场。待全部建成后，该园区将成为强生在全球的生产基地之一，同时容纳多个品牌的医疗和诊断器械产品的生产。

强生全球财务共享服务中心（亚太区）

Johnson & Johnson Global Finance Service

强生全球财务共享服务中心（亚太区），是强生在苏州设立的财务共享服务中心，向强生亚太地区各业务集团及分支提供AP/AR/GL服务，涉及的国家和地区包括中国大陆、香港、台湾、日本、韩国（泰国和巴基斯坦在计划中），并与将来强生在亚太其他地区设立的共享服务中心一起，组成强生亚太共享服务网络。

强生全球财务共享中心，是强生一分支机构，面向强生全球所有运营公司提供专业的财务服务，目前总部设于美国新泽西州的新不伦瑞克，各服务中心分别位于美国（新泽西州的新不伦瑞克和斯基尔曼），欧洲（捷克的布拉格），拉丁美洲（巴西的圣保罗），亚洲（中国苏州，菲律宾的马尼拉）。

Overview of Global Business Services - Asia Pacific

-In todays world, each of J&Js businesses (or sectors) have different approaches to how finance processes are being handled. Specifically for transactional finance processes, some businesses have local finance perform the tasks, whereas others have outsourced to external vendors.

-Global Business Services or GBS Asia Pacific, is the regional financial shared service center that will support selected finance processes across all sectors of J&J

-There will be 2 centers established to support Asia Pacific, of which one will be set up in Suzhou. The other location is pending confirmation

-Office location:

J&J has a new campus facility in Suzhou Industrial Park. The new office for GBS-AP will be ready in early 2010.

In the meantime, GBS-AP will operate out of the temporary office which is also located within SIP.

Suzhou will support the following countries: China, Taiwan, HK, Korea and Japan.

Countries will transition the in-scope finance processes to the shared service center by waves. This is to mitigate operational risks and also managing other ongoing initiatives in J&J where there are dependencies

The 1st wave of countries identified will transition to Suzhou by late October 2008.

All in-scope processes to be supported out of Suzhou will be completed by 2011.

Estimated size of organization by 2011 is around 160 to 180 people

All employees of GBS will be part of the J&J family, i.e. they are J&J employees

Where an individual shows potential, there is an opportunity for talent mobility, i.e. movement within GBS-AP or to other J&J companies