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Quality Regulatory Compliance 质量

公司行业:
苏州制药/生物工程招聘
公司规模:
100-199人
公司所在地:
苏州(进入苏州招聘网
公司性质:
外贸独资.外企办事处
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正查看洁定医疗器械(苏州)有限公司招聘Quality Regulatory Compliance 质量信息,还可查看“苏州其他质量安全职位”招聘信息。

职位编号:86762338 职位描述 (苏州Quality Regulatory Compliance 质量招聘 )
职位描述/要求:

Main responsibilities:

Regulatory Compliance

•Liaison between the corporate international regulatory team, SA & ME SSU’s and regulators to support SSU and corporate compliance with applicable laws and regulations.

•Raise product clearance requests for new product licenses, license amendments and renewals as per Global SOP (Standard Operating Procedures).

•Review product registration dossiers from corporate international regulatory team.

•Assist with ensuring all Arjo products supplied in the Middle East Region are registered with the applicable regulatory body using supplied product registration dossiers.

•Ensure Arjo products supplied in the Middle East are compliant with local or international standards where mandatory or required.

•Create processes within local Quality Systems to ensure new product is registered in a timely manner and cannot be supplied to customers without the correct legal requirements in place.

•Communicate any discrepancies, delays or requirements with the corporate international regulatory team in a timely manner.

•Prepare documentation for the purpose of registration with the regulatory bodies

•Obtain required documentation from the manufacturer to meet regulatory body audit requirements for Arjo products.

•Liaise with SSU Management teams to provide corporate international regulatory team with an annual report for product clearance planning activities for the next calendar year.

•Provide corporate international regulatory team updates to market regulatory requirements, relevant laws and regulations.

•Liaise with local sales teams, importers and distributors to ensure compliance with SOP’s regarding product registrations, import and marketing, providing training as appropriate.

•Maintain local records of distributors contacts, establishment licenses and associated product license

•Coordinate activities to support supplier audits of SSU and corporate facilities by regulators.

•Provide monthly report on area activities to the Regional Director RoW and corporate international regulatory team.

Post Market Activities

•Document and process all Incident Reports with the relevant regulatory body ensuring the investigation, reporting and finalization are dealt with appropriately and in line with regulatory, Arjo requirements.

•Liaise with the relevant Arjo Vigilance and Regulatory Bodies to create and issue field action documentation to the customers or facilities.

•Document and process all Incident Reports as instructed by Global Vigilance ensuring the investigation, reporting and finalization are dealt with appropriately and in line with regulatory requirements.

•Conduct and/or assist/supervise local staff to conduct incident investigations

•Document and process all product recalls, TAN, SAN, FSN and Stop Orders ensuring the investigation, reporting and finalization are dealt with appropriately and in line with regulatory requirements.

•Ensure Field actions TAN, SAN or FSN are coordinated and co

该“苏州Quality Regulatory Compliance 质量招聘”的职位信息由洁定医疗器械(苏州)有限公司发布,如果您想找苏州Quality Regulatory Compliance 质量的工作,可以直接在线申请该职位。苏州招聘网提醒您:一份完整的简历会受到更多企业的青睐,不要忘记经常更新您的简历哦。
职位类别:
其他质量安全职位
更新日期:
2018/5/23
职位性质:
全职
工作地点:
苏州-工业园区
学历要求:
本科及以上
招聘人数:
1人
最低工作年限:
3-5年
月薪范围:
面议
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洁定医疗器械(苏州)有限公司联系方式:

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洁定医疗器械(苏州)有限公司简介

而久是一个有着瑞典文化的国际化跨国公司。在其文化领导的国际环境中蓬勃发展。公司提倡以人为本的核心价值观,我们所做的每一件事都遵从以人为本的原则。客户所面临的需求和挑战一直激励着我们不断发展,我们的员工就是企业的推动力,着重于为客户创造最好的价值。

ARJO is a globally minded company with a Swedish heritage, where a thriving international environment is driven by Swedish leadership culture. Everything we do - we do with people in mind. Our motivation lies in the needs and challenges our customers face, and our driving force is our people, who care about creating the best possible outcomes for our customers.

ARJO延伸护理业务,最先进的医疗延伸护理技术。

The ARJO extended Care, the most advanced medical extension nursing technology.

在全球卫生保健和生命科学领域内,而久延伸护理业务处于领先地位。 自100多年前成立至今,而久延伸护理业务成为了科技进步的象征。

In the field of global health care and life sciences, the extended care business is in the lead. Since its establishment more than 100 years ago, ARJOs extended care business has become a symbol of technological progress.

而久延伸护理业务机构遍布全球,在六大洲有多个子公司、以及多个经销商和代表而久的销售、服务合作公司。

The ARJO Infection Control organization is to be found all over the world, with 29 subsidiaries on six continents and over 230 distributors and partner companies in sales and service representing ARJO Infection Control.

涵盖的业务

Business activities

为卫生基础护理、老年人/残疾人护理提供系统产品服务,以减低他们行动的困扰和痛苦。

Systems for hygiene routines and the transfer of the elderly and disabled, as well as products that prevent and treat pressure sores.

所涵盖的产品范围有:防褥疮床垫和预防深度静脉血栓系统。

The product range covers prevent deep vein thrombosis products and medical prevent bedsore products.

而久的核心价值观/Core value

“以人为本”——公司秉持的核心价值观,使而久在众多竞争对手中彰显特色。

“With people in mind” are the core value of the company that will characterize ARJO’s business.

公司地址:苏州市-苏州园区


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公司地址:苏州工业园区方洲路158号