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
苦情担当スペシャリスト担当製品: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
安全管理部門の一員として、以下の業務を行う。
-苦情処理:顧客から挙げられた製品に対する苦情報告内容を確認し、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。
-監査対応等:内部監査、外部機関からの監査対応やサポートをする。
-トレンド分析:製品群ごとに苦情報告のトレンドを解析する。
1. 苦情処理とPMDA報告書の作成
医療機関・代理店から上がってきた苦情報告を確認し、必要に応じて追加情報の収集を行う。
また、国内においてPMDA報告要否の判定を実施し、報告要となった症例についてはPMDAに行政報告を行う。
2.添付文書管理
IFUの改訂内容を確認し、必要に応じて添付文書改訂を行う。
RAが実施する軽微変更や一部変更で生じた変更について、PMDAに事前相談を行い、添付文書改訂を行う。
3.監査対応
内部、外部の監査に向けて事前準備を行い、監査当日の対応を行う。
Must Haves
Knowledge/Education:大卒以上
Job Experience:薬機法に基づく品質保証又は品質管理経験(医療機器業界が望ましい)
Competencies/Language Skills: コミュニケーション/交渉力、プレゼンテーションスキル、実務での英語読解/
ライティング経験/日本語ネイティブレベル
Computer Skills: PowerPoint/Word/Excel
Nice to Have
- :薬機法の知識、QMS省令、ISO13485 等の規格の知識
Skills/Competency: プロジェクトマネージスキル
Computer Skills: エクセルスキル中級(トレンド分析・集計業務の確認など
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.
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
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