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
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
Maintenance Engineerll Introduction about us At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services,
Job Description Summary生産ラインの安定稼働と一貫した品質を確保するため、製造現場の日々のオペレーションを遂行・管理する。サービスショップを含む担当領域において、部門運営に影響を与える計画立案および実行責任を担う。標準化された手順および業務プロセスに基づき、自律的に業務を遂行しつつ、必要に応じて上位者の指導のもと判断・対応を行う。 Perform the daily operations of plants to ensure reliability and consistency on the production line. Includes Service Shops. Impacts departmental operations and responsible for planning/execution. The role has some autonomy but is focused
Job Description SummaryCoordinate and expedite the flow of materials (from suppliers and also within departments) according to production schedules. Plan and schedule material/production needs. Impacts departmental operations and responsible for planning/execution. The role has some autonomy
Company Overview : Dozee Health AI is the pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company. We are
JOB DESCRIPTION: Primary Function Provides global or regional leadership for a particular regional or global clinical program. Ensures design and execution of high quality clinical studies to ensure safety and effectiveness of the company’s products. Manages
About Zscaler Zscaler accelerates digital transformation to ensure our customers can be more agile, efficient, resilient, and secure. As an AI-forward enterprise, we are constantly pushing the envelope, leveraging the world’s largest security data lake to
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
Req ID: 133254 Remote Position: No Region: Asia Country: Japan State/Province: Miyagi City: Miyagi General Overview Functional Area: OPS - Operations Career Stream: CPM - Customer Program Management Role: Specialist SAP Short Name: SPE Job Title:
Req ID: 133251 Remote Position: No Region: Asia Country: Japan State/Province: Miyagi City: Miyagi General Overview Functional Area: Supply Chain Management (SCM) Career Stream: Purchasing (SCM_PUR) Role: Analyst Job Title: Buyer Job Code: ANA-SCM-BUY Band: Level
Req ID: 133253 Remote Position: No Region: Asia Country: Japan State/Province: Miyagi City: Miyagi General Overview Functional Area: Supply Chain Management (SCM) Career Stream: Planning & Inventory (SCM_PNIV) Role: Analyst Job Title: Planner Job Code: ANA-SCM-PLAN
About Convatec Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy
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
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
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
Appealing Points: An opportunity is available with a leading Japanese medical device company for a long-term and scalable engagement. As this is a new business, the selected candidate will become a core member, contributing significantly to the companys