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
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce
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
Worker Sub-Type:Regular Job Description: Are you the person we are looking for? QNX enhances the human experience and amplifies technology-driven industries, providing a trusted foundation for software-defined businesses to thrive. The business leads the way in
OVERVIEW: Guidepoint’s Human Resources team thrives on problem-solving and creating happier employees. As Guidepoint works to achieve its mission of making individuals, businesses, and the world smarter through personalized knowledge-sharing solutions, the Tokyo, Japan office is
Do you want to change how the world creates? At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in
Responsibilities OBXtek is staffing positions for Instructor Combat Systems Officer/CI - on the MC-130J MDS for the Air Force Special Operations Command (AFSOC) 492 Special Operation Wing (SOW) and operational units. Instructors will provide instruction, in
Responsibilities OBXtek is staffing positions for Contract Instructor Pilots/CI on the MC-130J MDS for the Air Force Special Operations Command (AFSOC) 492 Special Operation Wing (SOW) and operational units at Kadena AB, Japan. Instructors will provide
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
Come join Analog Devices (ADI) – a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to
Company Description We are seeking a Senior RPO Recruiter to support end-to-end recruitment delivery for our client organization(s). This role will partner closely with hiring managers and internal stakeholders to drive high-quality hiring outcomes. The ideal
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a
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
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
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