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BD

薬事(RA) スペシャリスト/シニアスペシャリスト

Location:  Minato-ku, Japan
Location flexibility:  4 office days / week – Based on location and role requirements.
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Job 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

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Working at BD

4 office days / week – Based on location and role requirements.

A little flex time – Based on role requirements.

Company benefits

Health insurance
__ days annual leave + bank holidays
Accrued annual leave
Company shutdown periods
Optional unpaid leave
Reservist leave
Buy or sell annual leave
Compassionate leave
Dental coverage
Fertility benefits
Hertility subscription
Mental health pathway
On-site wellness services
Complimentary Medical Services
Eye Care Support
Fertility treatment leave
Men’s health support
Mental health platform access
Personalised nutrition plan
Wellbeing allowance
Women’s health support
Critical Illness Insurance
Family health insurance
Gym membership
Menopause support
Mental health first aiders
Mental health support
Private GP service
Wellbeing incentive programme
Mentoring
Coaching
Learning platform
Further education support
Study support
Professional subscriptions
Collaboration spaces
Bike parking
On-site wellness room
Secure on-site parking
Cycle to work scheme
On-site barista
Private booths
Sensory-Friendly Setup
Chill out zone
Ergonomic workstations
Meditation space
On-site catering
On-site gym
On-site shower
On-site workout classes
Adoption leave
Eldercare services
Shared parental leave
Pregnancy loss leave
Summer holiday childcare
Carer’s leave
Emergency leave
Pregnancy support
401K
Annual pay rises
Equity packages
Salary advance
Additional voluntary pension contribution
Electric Car Salary Sacrifice
Income protection
Life assurance
Salary sacrifice
Nursery salary sacrifice scheme
Annual bonus
Enhanced pension match/contribution
Life insurance
Referral bonus
Share options
Theme park discounts
Cinema discounts
Coffee discounts
Restaurant discounts
Travel insurance
Employee recognition scheme
Career and family coaching
Death in service
Employee discounts
Sabbaticals
Sports teams
Workplace loan
Charity donation scheme
Company wide holidays/offsites
Financial advice
Relocation packages
Teambuilding days
Volunteer days
Car allowance
Company car
Employee assistance programme
Financial coaching
In house training
Neonatal leave
Physiotherapy
Will writing
Modern office
Enhanced maternity leave
Enhanced paternity leave
Tax-free childcare
Women’s health leave
Enhanced maternity leave
Women’s health leave
Non-contributory pension
Religious celebration leave
Bank holiday swaps
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Company employees:

60,000+

Office Locations