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Stryker

Lead Specialist, Regulatory Affairs

Tokyo, Japan

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

The Job's Mission

Under minimum supervision by Manager, he/she understands the related laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks.

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マネジャーの最小の指導の下、薬機法全般に精通し、豊富な知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。

Key Activities & Accountabilities

Responsibilities of this job is the appropriate execution of approval applications/notifications for medical devices which Stryker Japan K.K. manufactures and distribute. The duties are as follows:

  • Manufacturing and distribution/certification approval, notifications (including planning, collecting data, and PMDA/NB query correspondence)
  • Maintenance of approvals and certifications (Change control and periodical renewal)
  • QMS compliance inspection applications
  • Insurance listing applications (Creation of insurance listing application forms)

当社が製造販売する医療機器に係る下記を中心とした薬事申請業務の適切な履行を職責とする。

  • 製造販売承認/認証申請、届出 (計画立案、資料取集、PMDA/NB 照会対応)
  • 承認/認証の維持管理業務 (変更管理、定期更新)
  • QMS適合性調査申請
  • 保険収載業務 (保険適用希望書作成等)

Education

  • Language Skills (he/she is able to read and write English)
  • He/she has an ability to write the business documents
  • 語学力 (英語による文語でのコミュニケーションが実施できる。)
  • ビジネス文書を書くスキルがある。

Experience

  • 6+ years of experience of medical device (Class I to IV) application approvals
  • Good communications skills and project management skills
  • 医療機器 (クラスI~IV) の薬事申請における最低6年程度の実務経験
  • コミュニケーションスキル、プロジェクトマネジメントスキル

Competencies

  • Not only high level of expertise required to the job, he/she needs to show a good communication skill in the organization. He/she can utilize the skill and communicate efficiently with internal related sections such as QC, WA, Sales & Marketing, Operations, Customer Care and etc.
  • He/she needs to have integrity and action-oriented mindset.
  • Please describe in detail the history of approval / certification application and the role you played in your resume.
  • 業務に必要な専門性のみならず、組織の中で、円滑にコミュニケーションが取れる人材。社内関連部門 (薬事、品質保証、品質管理、営業、マーケティング、オペレーション、カスタマーケア等) との良好かつ円滑なコミュニケーションが実施できる。
  • 誠実な対応、率先して行動できる人材
  • 職務経歴書に、承認• 認証申請の履歴と担った役割を詳細に記載してください。

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.

Client-provided location(s): Tokyo, Japan
Job ID: Stryker_Combined-u3t5pklFxk22
Employment Type: Other

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • FSA With Employer Contribution
    • HSA
    • HSA With Employer Contribution
    • On-Site Gym
    • Mental Health Benefits
    • Virtual Fitness Classes
  • Parental Benefits

    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
    • On-site/Nearby Childcare
  • Work Flexibility

    • Flexible Work Hours
    • Remote Work Opportunities
    • Hybrid Work Opportunities
    • Work-From-Home Stipend
  • Office Life and Perks

    • Casual Dress
    • Happy Hours
    • Company Outings
    • Commuter Benefits Program
    • Snacks
    • Some Meals Provided
    • On-Site Cafeteria
    • Holiday Events
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Personal/Sick Days
    • Sabbatical
    • Leave of Absence
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Company Equity
    • Stock Purchase Program
    • Performance Bonus
    • Relocation Assistance
    • 401(K)
    • Financial Counseling
  • Professional Development

    • Tuition Reimbursement
    • Learning and Development Stipend
    • Promote From Within
    • Mentor Program
    • Shadowing Opportunities
    • Access to Online Courses
    • Lunch and Learns
    • Internship Program
    • Work Visa Sponsorship
    • Leadership Training Program
    • Associate or Rotational Training Program
  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program
    • Employee Resource Groups (ERG)

Company Videos

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