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＜ポジション名＞
GVP Specialist
＜部門について＞
Post Market VigilanceはGVP省令に基づいた市販後の安全管理を行う部署です。
ポートフォリオ毎のチームに分かれ、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します。
＜チームについて＞
CVは循環器内科、心臓血管外科等の心臓周辺に関連するデバイス（ペースメーカー、ステント、バルーンカテーテル等）を扱うチームです。自身の仕事に関しては自身で裁量を持ってもらい、マネージャーは必要な時にサポートすることで個人の力量を伸ばすことを目指しています。2025年12月現在、合計16人のチームで30代、40代がメインです。
＜業務内容＞
苦情処理：顧客から報告された製品に対する苦情内容を確認し、必要に応じて追加情報の収集を行う。
行政報告：国内外から受理した苦情内容を評価し、必要に応じてPMDAに報告を行う。
添付文書管理：海外製造元が作成するIFUの改訂またはRAが行う軽微変更や一部変更に合わせて添付文書の記載内容を改訂する。
監査対応：内部監査、外部機関からの監査対応やサポートをする。
行政対応：苦情処理や行政報告、添付文書の改訂に伴うPMDAやMHLWとの折衝を行う。
＜Must Haves＞
Job Experience
医療機器業界での品質保証に関する職務経験
Skill / Knowledge
実務での英語スキル（Reading & Writing）またはTOEIC 700点以上
Microsoft PowerPoint, Word & Excel
Competency
コミュニケーション/交渉力
プレゼンテーションスキル
Education
学士以上（学部・学科は問わない）
＜Nice to Haves＞
Job Experience
GVP業務経験
QMS業務経験
医療機器業界での何かしらの業務経験
プロジェクトマネジメント
Skill / Knowledge
実務での英語スキル（Speaking）
ISO13485等の規格の知識
＜Working Style＞
勤務地：品川本社（リモート可）
基本的にテレワーク可能
月数回の品川オフィスへの出社
ベネフィット
メドトロニックでは、会社の成功と社員の成長は共にあるべきであると考えています。社員一人ひとりの経済的、身体的、精神的な幸せを高められるような、充実した福利厚生と報酬プログラムを用意しています。
年間最大36万円の育児費用補助
家族に介護が必要になった場合や養子縁組の際などに6週間取得できる休暇制度
ベビーシッターや保育園のマッチングサービス
メンタープログラムやe-learningなどを含むキャリア開発
女性の活躍を支援する社内キャリアネットワーク
自社株購入制度 etc.
その他
＜諸手当＞
通勤手当、勤務時間外手当、休日勤務手当 etc.
＜休日＞
土曜日、日曜日、祝祭日 etc.
＜休暇＞
年次有給休暇、公傷病休暇、生理休暇、産前産後休暇 etc.
＜勤務時間＞
9：00～17：30
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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
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).
Skills Required
- Bachelor's degree (or foreign equivalent meeting 8 C.F.R. §214.2(h)(4)(iii)(A) requirements) plus 2+ years related experience, or advanced degree with 0 years experience
- Experience with Medical Device Reports (MDR) and adverse drug event (ADE) reporting
- Experience reviewing and analyzing clinical databases and extracting ADE data
- Experience developing regulatory reporting programs and processes and working with internal and external stakeholders
- Ability to ensure accuracy and quality of safety summaries and maintenance of unified safety databases
Medtronic Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.
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Parental & Family Support — Paid leave for birthing and non-birthing parents is positioned as notably generous, with additional Family Care Leave available for a range of caregiving needs. Fertility, adoption, donor, and surrogacy support adds depth for different paths to family-building.
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Retirement Support — A 401(k) match and an employee stock purchase plan are presented as meaningful long-term savings tools. Scholarship and tuition programs further reinforce financial security beyond salary.
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Healthcare Strength — Medical, dental, and vision coverage is consistently described as a strong part of the total rewards package. Mental health resources, critical illness coverage, and wellness supports broaden the overall health offering.
Medtronic Insights
What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
