Specialist A P in Tokyo

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life JOB TITLE: シニア薬事スペシャリスト DEPARTMENT: 品質保証・薬事（薬事Cardiovascular/DIBポートフォリオ） REPORTING TO: 薬事マネジャー ********************************************************************************************** Main Mission of Job “Being a “bridge” to deliver “meaningful” medical device to Japanese patients” 日本の患者さんに価値のある医療機器を届ける架け橋となる Main Responsibilities 血管内治療機器に関連する薬事業務に従事いただきます。 新製品のタイムリーな国内導入に向け、その製品特性、開発計画、市場およびビジネス上のニーズ、上市戦略を理解し、米国本社およびマーケティング部門と協力して、薬事承認および保険に関する申請戦略および作業計画を立案する。 薬事申請戦略および作業計画に基づき、米国本社および国内関連部門の協力を得て必要な情報を収集し、行政当局との相談を行いながら、質の高い申請書を効率よく作成して審査当局に提出し、承認取得する。 保険申請戦略に基づき、必要な申請書を作成し当局に提出する。区分C1またはC2申請を行う場合は、マーケティング部門、保険担当部門と協力して、国内外のエビデンスの収集、保険適用申請書の作成と提出、説明資料の作成、関連学会や行政当局との折衝を行う。 製品の流通に際し、モデル情報の登録や帳票類の整備等、付帯する薬事関連業務を行う。 米国本社との良好な信頼関係とコミュニケーションを維持して、必要な情報をタイムリーかつ正確に取得し、薬事行政上の必要な判断や措置を遅滞なく講じる。 国内薬事関連法令やグローバルな薬事行政の動向、担当する製品群および関連治療についての最新の情報・知識を収集する。 業界活動を通じ、品目の基準作成、薬事関連、保険関連などにおいて、業界側の考えを行政に提案する。 Must Haves 学士（４年制理系大学卒）以上又はそれに相当する学位 医療機器又は医薬品の薬事申請業務（クラスⅣの医療機器の薬事申請経験があれば尚可） 米国本社との情報交換及び技術英語読解に必要な英語能力

Who We Are Notion is the collaborative AI workspace where teams and agents think together . We're building one place where your knowledge, projects, meetings, and AI tools live side by side, so work is faster, clearer, and less fragmented. Millions of individuals, small teams, and large companies run their work on Notion. Notinos (our employees) are customer zero in bringing this future of work to life. We care about craft, building things that last, and the belief that great work is still fundamentally human. Our goal isn’t to ship the next feature. Each and every team of Notinos is working to set the standard for how humans work together in the AI era. From building a business’s system of record to making and managing AI agents to automating away the busy work, we care deeply about giving our customers more time for their life’s work. About The Role We’re looking for an experienced Localization Project Manager — Japan Training Quality to support localization for Customer Education, helping ensure Notion training content feels accurate, clear, culturally relevant, and ready to use for learners across the globe. You’ll work at the intersection of localization quality, training implementation, and program management , collaborating with Localization, Partner Enablement, Customer Education, vendors, and language specialists. You’ll help turn translation feedback, learner experience issues, and regional quality needs into practical improvements across training content, quizzes, LMS setup, and repeatable localization workflows. The ideal candidate combines native-level Japanese language expertise with a deep understanding of what effective education looks like in the Japanese market. What You'll Achieve Own and apply Japanese localization QA standards across training content, including checking for accuracy, clarity, tone, terminology, and cultural nuance Support development of glossaries, style guides, QA checklists, review processes, and localization assets Become a g