薬事(RA) スペシャリスト/シニアスペシャリスト at BD Canada

Minato-ku, Tokyo, Japan -

Full Time

Start Date

Immediate

Expiry Date

12 Oct, 26

Salary

0.0

Posted On

14 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Device Approval Strategy, PMDA Negotiation, Pharmaceutical and Medical Device Act, QMS Compliance, GCP, Project Management, English Proficiency, Japanese Proficiency, Technical Writing, Regulatory Submission, Compliance Management

Industry

Medical Equipment Manufacturing

Description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description グローバルの最前線で生まれる医療技術を、日本市場へ。薬事スペシャリスト／シニアスペシャリストとして、医療機器（クラスI〜IV）の承認戦略から上市後管理までを担い、製品ライフサイクル全体に関与いただくポジション。申請業務にとどまらず、開発初期からプロジェクトに参画し、コンプライアンスを徹底しながら、事業戦略に沿った市場投入をリードしていただきます。また本ポジションは、R&Dやプロダクト開発、QAで培った経験を薬事領域で活かしたい方にもオープンです。リサーチの読解・理解から、論理的な整理・文書化に至る一連のスキルを基に専門性を広げていただけます。職務内容医療機器（クラスI～IV）の薬事申請資料の作成・レビュー・提出（承認申請書、添付資料、QMS適合性調査申請書等）独立行政法人医薬品医療機器総合機構（PMDA）および厚生労働省との折衝、照会事項対応製品開発段階からの薬事戦略立案および申請スケジュール管理上市後の薬事維持管理（軽微変更届、一変申請、定期報告等）法規制の動向把握と社内への情報展開 SOPの整備、社内トレーニングの実施海外本社・グローバルチームとの連携【必須/ Must】ライフサイエンス系学部または関連分野における学士号以上。優れたコミュニケーション能力、交渉能力、プレゼンテーション能力。論理的思考力と問題解決能力。能動的かつ責任感を持って業務に取り組める方。日本語：ネイティブレベル、英語：ビジネスレベル【歓迎（WANT）】医療機器または医薬品の薬事申請業務経験3年以上（スペシャリスト）または5年以上（シニアスペシャリスト）。薬機法、QMS省令、GCPなど、日本の医療機器関連法規制に関する深い知識。 PMDA/認証機関との折衝経験。プロジェクトマネジメントスキル（シニアスペシャリストに求められる）。 Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work Location JPN Tokyo - Minato-ku Additional Locations Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Responsibilities

Responsible for the entire product lifecycle of medical devices (Class I-IV), from approval strategies and PMDA negotiations to post-market management. The role involves creating regulatory submission documents and collaborating with global teams to ensure compliance and market entry.