JOB DESCRIPTION: MAIN PURPOSE アボットメディカルジャパンが取り扱う循環器領域の医療機器（主にクラスⅣの高度管理医療機器）において、薬事担当者として高い専門性と自立性をもって薬事業務を主導し、製品の承認取得およびライフサイクル全体にわたる規制対応を推進します。 シニア～プリンシパルレベルの 個人貢献型プロフェッショナル として、複雑性の高い案件や関係部門・規制当局との調整をリードする役割を担います。 MAIN RESPONSIBILITIES - 当社製品における承認申請、変更申請、定期報告等の作成・提出の主担当 - 規制当局（PMDA等）との照会対応、折衝を通じた承認取得の推進 - 製品ライフサイクル全体（開発～上市後）における薬事対応のリード - 社内関係部署（研究開発、品質、製造、マーケティング等）との横断的な調整および助言 - 規制要件・ガイドラインの解釈を踏まえた薬事方針の検討・提案 - グローバル薬事チームとの連携、情報共有、英語での会議・文書対応 （プリンシパル相当の場合） - 組織内における薬事の専門的相談窓口 - 若手薬事メンバーへの助言・支援 QUALIFICATIONS 必須要件 - 理系学士卒以上（修士・博士歓迎） - 医療機器薬事の実務経験：5年以上 - クラスⅢ／Ⅳ 医療機器に関する薬事経験
Job Description SummaryPortfolio Management & LCM Lead The role is responsible for executing portfolio and late lifecycle management activities for assigned mature and non priority brands, ensuring disciplined budgeting, performance vigilance, and operational continuity. The position
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Requistion ID: 83576 Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and
Our world is transforming, and PTC is leading the way.Our software brings the physical and digital worlds together, enabling companies to improve operations, create better products, and empower people in all aspects of their business. Our
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Job Description: Business Overview Rakuten Group provides over 70 services in a wide variety of fields, including internet services such as e-commerce, travel, and digital content; fintech (financial) services such as credit cards, banking, securities, electronic
■会社概要（About TableCheck） TableCheckは「Dining Connected ～世界中のレストランとカスタマーをつなぐプラットフォーム～」をミッションに掲げる日本発のレストランテックカンパニーです。私たちは、テクノロジーを駆使して次世代の「おもてなし」を実現し、飲食店向けの予約・顧客管理システムやユーザー向けの飲食店検索・予約ポータルサイトを提供しています。24時間365日リアルタイムで空席情報を把握することで、飲食店とユーザー双方にとって最適なレストラン体験をサポートします。 また、ゲスト向けの新しいサービスのリリースなど、多様なサービスを展開し、常に成長し続けています。私たちは、革新的なサービスの提供を通じて業界のリーダーとしての地位を確立し、お客様に最高の体験を提供することを目指しています。 TableCheckは、成長著しいフェーズにあり、共に成長できる仲間を求めています。私たちと一緒に、お客様に最高の体験を提供するための挑戦に参加しませんか。 TableCheck is a global platform built to help restaurants own their guest experience. We help merchants reduce their reliance on paid booking channels by directly converting first-time diners into
Company Overview KLA is a global leader in diversified electronics for the semiconductor manufacturing ecosystem. Virtually every electronic device in the world is produced using our technologies. No laptop, smartphone, wearable device, voice-controlled gadget, flexible screen, VR device or
Company Overview KLA is a global leader in diversified electronics for the semiconductor manufacturing ecosystem. Virtually every electronic device in the world is produced using our technologies. No laptop, smartphone, wearable device, voice-controlled gadget, flexible screen, VR device or
Job Description SummaryThe Senior Systems Engineer provides advanced systems engineering leadership for diagnostic ultrasound products and platform development, with responsibility for system requirements, design analysis, subsystem integration, technical tradeoff decisions, risk management, and system verification and
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Pall Corporation, one of Danaher’s 15+ operating companies, our work saves lives—and we’re
Company Description Sandisk understands how people and businesses consume data and we relentlessly innovate to deliver solutions that enable today’s needs and tomorrow’s next big ideas. With a rich history of groundbreaking innovations in Flash and
Appealing Points: Lead End-to-End Medical Software Development – Drive the design, architecture, and delivery of enterprise-grade medical software from requirements through deployment. Technical Leadership with Global Collaboration – Lead cross-functional and offshore teams while working closely with customers