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    法規(guī)主管QARA Supervisor

    刷新時間:2023-11-28

    Shanghai SOL-Millennium Medical Products Co., Ltd

    面議

    上海市 | 本科 | 3-5年

    基本信息
    工作地點(diǎn):上海市 所屬部門:QARA
    職位類別:商務(wù)專員/助理 招聘人數(shù):1 人
    匯報對象:無
    職位描述

    Responsibilities:

    -Responsible for complaint handling, Driving compliant closure and response for all complaints.



    - Maintain all complaint Handling materials/records and keep records complete and accurate.

    -Maintain performance of on-time reporting of MDRs/MDVs.

    -Maintain product safety and compliance and report field to regulatory agency

    -Assist in the development, implementation and maintenance of quality assurance programs. Ensure documents and records are kept in compliance with regulations and SOPs.



    - Support Global QARA team developing new or improving existing Quality Management Systems.



    - Manage on-line QMS system rolling out with the cross-function departments in APAC region and maintain the daily operation.



    -Follow up RA registration plan and monitor registration schedule.



    - Responsible for all Registration projects in APAC regions.



    - Lead and coordinate registration material preparation for new products launching into market.

    - Provide regulatory support and review on the relevant documents and reports.



    -Provide technical advice on trending of data and quality systems as relates to annual reporting, management metrics and other trending, as required




    Qualifications:

    -Bachelor or above

    -Fluent English both in writing and oral

    -At Least more than 5 years’ Medical device QARA experience

    -Project management experiment.

    -Knowledge: A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field

    Problem solving: Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires uation of identifiable factors


    崗位要求:
    學(xué)歷要求:本科 工作經(jīng)驗(yàn):3-5年
    年齡要求:不限 性別要求:不限
    語言要求:普通話 專業(yè)要求:不限
    企業(yè)信息
    公司性質(zhì):其它 公司規(guī)模:100-499人
    所屬行業(yè):醫(yī)療設(shè)備/器械
    企業(yè)介紹

    The Sol-Millennium Group is dedicated to Building a Healthier Tomorrow and helping people live in a healthier world.? Our team members are committed to improve the safety and well-being of healthcare workers and their patients with the design and development of safety medical devices.????? Sol-Millennium Group is a Global Healthcare Company providing innovative products and value added services through product development, manufacturing and distribution targeting safe injections and disposal of medical devices.? Our belief that the front line professionals are critical in the development process, we continually are in touch to share knowledge, ideas with concentration on the improved functionality of injection safety which is led by our experienced Research and Development team.? The Sol-Millennium culture focuses on continuous improvement, technological innovation and customer service.

    http://www.sol-m.com

    企業(yè)信息

    Shanghai SOL-Millennium Medical Products Co., Ltd

    醫(yī)療設(shè)備/器械

    100-499人

    其它

    上海市浦東新區(qū)世紀(jì)大道1777號東方希望大廈11樓E座

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