At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

薬事申請担当者として、医療機器等の規制要件を遵守し、製品の承認・認証取得および維持に必要な薬事申請業務を担当する。また、新製品の申請業務に加え、既存製品の変更管理や承認維持に関連する薬事対応を通じて、製品が日本市場でタイムリーかつ継続的に使用可能となるよう貢献する重要な役割を担う。

主な業務内容

１．薬事申請書類の作成、提出、照会対応、承認等の取得

2. PMDAおよび認証機関等との対面助言を含む相談の業務

3. 既存製品の変更管理に関する薬事対応

4. 米国製造元及び社外及び社内関連部署との連携及び協力体制の構築

5. 保険収載業務（保険適用希望書作成等）

必要なスキル・資格

• 学歴: 薬学、工学、生物学、または関連分野の学士号以上。
• 経験: 医療機器の薬事申請業務の実務経験（最低3年）。
• 知識:日本の医療機器関連法規（医薬品医療機器等法、ISO 13485など）。
• スキル: タイムマネジメント力、日本語および英語での優れたコミュニケーション能力、業務に積極的に、かつ、誠実に取り組む姿勢

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here