MDR/Vigilance Specialist job opportunity at Medtronic plc.

Home Jobs In Japan Tag: Job MDR/Vigilance Specialist position at Medtronic plc


DateMore Than 30 Days Ago bot
Medtronic plc MDR/Vigilance Specialist
Experience: General
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeGeneral
loacation Tokyo, Tokyo, Japan, Japan
loacation Tokyo, Tokyo, ..........Japan

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    

Other Ai Matches

Field Tech Svc Spec Applicants are expected to have a solid experience in handling Job related tasks
Supplier Quality Engineering Manager Applicants are expected to have a solid experience in handling Job related tasks
Senior Clinical Specialist - CAS, St. Louis, MO, Shreveport, LA, Memphis, TN and Little Rock, AR Applicants are expected to have a solid experience in handling St. Louis, MO, Shreveport, LA, Memphis, TN and Little Rock, AR related tasks
Principal EP Mapping Specialist, CAS Applicants are expected to have a solid experience in handling CAS related tasks
Principal Technical Services Support Specialist Applicants are expected to have a solid experience in handling Job related tasks
Sales Representative II, Pain Therapies - Spokane, WA Applicants are expected to have a solid experience in handling Pain Therapies - Spokane, WA related tasks
Remote Sales Representative Applicants are expected to have a solid experience in handling Job related tasks
CRDN-Senior Technical Sales Representative-Jinan Applicants are expected to have a solid experience in handling Job related tasks
Clinical Support Project Coordinator III SSC Applicants are expected to have a solid experience in handling Job related tasks
HR Generalist MiniMed Applicants are expected to have a solid experience in handling Job related tasks
Ing. Calidad I (6 meses) Applicants are expected to have a solid experience in handling Job related tasks
Prin. Vascular Clinical Specialist - Gainesville, Florida Applicants are expected to have a solid experience in handling Florida related tasks
Affera Mapping Specialist- Charleston, SC Applicants are expected to have a solid experience in handling SC related tasks
Prin Business Process Improvement Analyst. Applicants are expected to have a solid experience in handling Job related tasks
Account Manager II - Surgical Innovation Applicants are expected to have a solid experience in handling Job related tasks
Field Sales Representative Interventional Pain Therapies (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
MiniMed Customer Service Manager Iberia Applicants are expected to have a solid experience in handling Job related tasks
Clinical Studies Spt Coord III - Mumbai Applicants are expected to have a solid experience in handling Job related tasks
Sales Representative II Applicants are expected to have a solid experience in handling Job related tasks
Field Service Engineer III Applicants are expected to have a solid experience in handling Job related tasks
Total Reward Operations Coordinator Applicants are expected to have a solid experience in handling Job related tasks
Principal Regional Field Educator Applicants are expected to have a solid experience in handling Job related tasks
Regional Manager - Neuroscience Applicants are expected to have a solid experience in handling Job related tasks