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【QA】MDR/Vigilance Specialist

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Quality
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200005DS Requisition #

DEPARTMENT:SAFETY CONTOLL

REPORTING TO:VIGILANCE MANAGER


Main Mission of Job

Careers that Change Lives

・メドトロニックのストラテジーを理解し、担当する事業部の製品についての製造販売後安全管理業務を遂行する。

・薬機法に関する諸規則を理解し、国内外の製品苦情・不具合について、法規制に則って製販としての対応を実行する。


Main Responsibilities

A Day in the Life

・担当する海外製造元、事業部および関係部門と連携して安全管理業務を適切に実施する。

・薬機法の規則および担当事業部の製品を理解し、国内外の市販後の製品苦情・不具合について評価・検討を実施し、法規制に則り、行政報告を含めた安全確保措置の検討を行い安全管理責任者に報告する。

・薬機法の法的要求事項を満たす各種手順書に沿った記録を作成する。

会社の総括製造販売責任者、国内品質業務運営責任者・安全管理責任者の指揮の下、マネージャの指示に従って会社の定めるQMSを遂行する。

・KPI達成のために作業効率改善及び成果物の質の向上に努める。

Must Haves

・大学卒同等以上

薬機法と市販後安全管理業務の知識と経験(医療機器の経験であればなお可)

・PMS対応経験があれば尚可

・英語力(TOEIC700点以上)

・コミュニケーション能力と協調性

・PCスキル(Excel, Word, Power Pointなどのオフィスツールを使える事)

・読解力、文章作成能力

・確実性、柔軟性、積極性、期限および業務改善に対する高い意識

・コンプライアンスに対する強い意識


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Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

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Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

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Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

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EMPLOYEE STORY:
ENGINEERING

Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

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We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.