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** **＜ポジション名＞ GVP Specialist (QA @ Tokyo)** **＜勤務地＞ 品川本社** **＜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。 **＜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＞** + 基本的にテレワーク + 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.  **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 (http://www.medtronic.com) 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. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com