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Medical Expert for Medical Device Risk
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Quality Manager for Software as Medical Device
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Quality Manager for Software as Medical Device
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Quality Manager for Software as Medical Device
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Medical Device Reporting Specialist
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Medical Expert
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Consulteer Munich, Deutschland**Medical Expert**: · Treibe den Ausbau unseres Medical Portfolios voran · MUNICH · **Deine Rolle & Verantwortlichkeiten** · - Aufbau/Umsetzung ISO13485 sowie FDA-Anforderungen · **Erforderliche technische & fachliche Expertise** · - langjährige Projekterfahrung mit Referenzen im ...
能動医療機器 技術文書評価アセッサー Technical Documentation Assessor for Active Medical Device - Munich, Deutschland - TÜV SÜD
Beschreibung
Aufgaben
リモートワーク可設計開発・臨床評価の経験を活かして、医療機器のエキスパートを目指しませんか?
募集部門
メディカルサービス事業部
業務内容
技術文書評価アセッサーとして下記の業務をお任せします。
・能動医療機器に対する国内外の法規制及び国際規格への適合性評価(臨床評価報告書のアセスメントを含む)
【能動医療機器とは】
電気等の動力エネルギーを利用して駆動する医療機器を指します。
例)X線、MRI, 内視鏡、超音波診断装置、補聴器、輸液ポンプ、透析装置など
【臨床評価報告書とは】
医療機器の臨床的な有効性及び安全性が評価された文書
ポジションの魅力
■多種多様な製品開発に携わることができる
医療機器業界の製造開発では一般的に一つの製品/領域に携わる期間が長期に渡るケースが多く、経験する製品分野が広がらず特化した経験になることが多くあります。
弊社では様々な医療機器メーカーの多種多様な製品に関わるため、先端技術の現場に立ち会うこともできます。
視野が広がり、より多くの経験を積み幅の広い経験を積むことが可能です。幅広い領域で医療機器メーカー業界の製造開発に貢献したいという想いをお持ちでしたら、叶えることができる環境が当社にはございます。
■早期にプロジェクトマネジメント経験を積むことができる
医療機器は特性上、製品の開発スパンが長期間に渡ることから、プロジェクトマネジメントを経験する機会が少ない傾向にあります。
弊社であれば1プロジェクトを単独で担当する機会も多いため、早期にプロジェクトマネジメントを経験することができます。
もし自身で裁量を持ち、早期にプロジェクトマネジメントを経験したいという想いをお持ちでしたら、ぴったりな環境だと自負しております。
■技術を磨きながらも語学力を生かした仕事に携われる
ドイツや他海外支社とのやり取りを通して、グローバルに活躍することもできるのが弊社の魅力です。
Qualifikationen
必須
■大卒以上(電気、電子系学科又は情報、ITセキュリティ系工学の学位保持者、または同等の知見)
■能動医療機器の臨床評価に関する2年以上の経験をお持ちの方
例えば、
・関連する文献のまとめ並びにそれらに対する評価報告書の作成経験
・評価対象となる製品もしくはそれと比肩しうる製品の市場における経験
・対象製品の臨床試験の経験
■能動医療機器の設計開発もしくは品質保証に関する2年以上の経験をお持ちの方
■ビジネスレベルの英語力(TOEIC730点目安)
歓迎
・能動医療機器の品質マネジメントシステムISO 13485に関するご経験
・内部監査員のご経験
・能動医療機器のMDRに関するご経験
・能動医療機器の電気安全、サイバーセキュリティに関するご経験
求める人物像
・素直で何事にも一生懸命に取り組める方
・継続的に自己研鑽を重ねることができる方
・誠実に粘り強く業務を遂行できる方
・一人一人の多様性を尊重しながらチームで仕事に取り組める方
・最新の製品や技術に幅広く携わりたい方(国内及び海外での製品・法規制・規格トレーニング参加の機会もあります)
・メーカーのビジネスパートナーとして、製品開発を側面支援する立場で活躍したい方
・製品の安全性を評価し、究極の目的である患者様及び医療従事者に安全な製品を届けることを側面でサポートする社会的 貢献度の高い業務に意欲を感じる方