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【RTG】Regulatory Affairs Specialist

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Regulatory Affairs
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20000EKR Requisition #

DEPARTMENT:       JAPAN Regulatory affairs Restractive therapy group 担当

REPORTING TO:  MANAGER

Main Mission of Job

<新たな治療・製品を本邦に導入することで社会に貢献する>


Main Responsibilities

Restractive therapy group、脳・脊髄・耳鼻領域の治療に係わる能動/非能動植込み機器、ナビゲーション、O-armなどのキャピタル機器、ドリル・電気メス等の手術器械など幅広い製品群(クラスI~IV)を扱うInnovativeExciteingな治療群です。

·        製造販売承認取得

o   担当する製品の特性に則した薬事申請戦略の立案

o   薬事申請戦略に基づく、承認申請書の作成

o   行政当局からの申請書に対する質問やリクエストへの回答作成

o   承認取得を目的とする申請前相談等の行政との折衝、関連学会・医師との連携・協力体制構築

·        製品上市準備

o   上市計画立案への参画

o   添付文書・法定表示等の作成

o   販売促進マテリアルの法的要求に係わる確認

·        製品の変更管理に関する判断、一部変更申請/軽微変更届の作成

·        上記に伴う米国本社、マーケティング、QA、教育等関連部署との関係構築、連携、協議

Must have
Knowledge

 基本的なビジネス知識

・電気機器に関する基礎知識

Job Experience
・医療電気機器に係わる経験又は生体材料に係わる経験

Skills/Competency Required

英語(メール・文書読解)

 技術文書の読解

 渉外力

自己管理能力

・問題解決意識

Nice to have

社内製品導入プロセス

・医療電気機器に関する知識またはソフトウェア規制に関する知識
医療機器メーカーにおける薬事業務(2年以上)

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

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Regulatory

Challenge 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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Be part of work that matters. 75 million patients had their health improved by our products last year.

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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

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