苏州Quality Regulatory Compliance 质量招聘-洁定医疗器械(苏州)有限公司招聘Quality Regulatory Compliance 质量-苏州才好网
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苏州才好网招聘 >> 苏州招聘 >> 苏州-工业园区招聘 >> 洁定医疗器械(苏州)有限公司招聘 >> Quality Regulatory Compliance 质量

Quality Regulatory Compliance 质量

公司行业:
苏州制药/生物工程招聘
公司规模:
50-99人
公司所在地:
苏州(进入苏州招聘网
公司性质:
其他
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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:
2018/5/27
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
更多
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

定医疗器械(苏州)有限公司企业介绍   洁定集团(GETINGE AB)已有百年历史,是全球领先的设备及系统供应商、服务商。始终致力于医疗保健机构及实验室的持续质量改进和不断成本节约。我们以ARJO商标,为病人卫生学、患者转运及伤口护理领域提供设备、服务及技术;以GETINGE商标,为医疗机构和实验室的感染控制及预防提供设备、服务及技术;以MAQUET商标,提供外科工作站,心肺机和重症监护领域的设备、服务及技术。

  GETINGE 洁定感染控制部门始终致力于为医疗机构和实验室提供有效、高效的清洗、消毒、灭菌系统解决方案。我们的专有技术和知识涵盖了医院感染控制系统建设的各个方面,从建筑设计、装修、无菌物品生产、质量控制、转运、到物流的示踪记录等。同时我们也为您提供专业咨询、培训及长期技术支持等业务。目前,洁定感控设备的全球市场占有率在25%以上,位居第一。

  洁定于1993年在中国设立了代表处,2000年设立中国客户服务中心。2005年成立洁定贸易(上海)有限公司,同年在苏州建立独资生产工厂――洁定医疗器械(苏州)有限公司。目前,已有200余家医疗机构、药厂、实验室选择了洁定的感染控制系统,愉快地享受着洁定的优质服务。

  通过与政府部门,专业学(协)会,专业杂志,医疗机构等的全面合作,洁定在提升并不断实现客户价值方面,有了更多的作为。特别是与卫生部感控培训基地的合作,以及与中华护理学会的合作。洁定在北大医院和瑞金医院设立了面向全国专业人士的“消毒供应培训中心”,在探索有中国特色专科护士培养和学术交流推广等方面的扎实工作,受到了用户们的一致推崇和赞扬。

  洁定也深深地认识到,今天的成功,是您不断鼓励和坚定支持的结果,对此,洁定将永远铭记在心,洁定将以更加细致入微的服务,回报您的爱心

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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