職務内容
マネジャーの最小の指導の下、薬機法全般についての知識と経験を有し、円滑な薬事申請及び関連業務の遂行を目的とする。
Under minimum supervision by Manager and Lead Specialist, he/she understands the laws and regulations, and efficiently conducts the duties such approval applications, notifications and other related tasks.
Key Activities & Accountabilities
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、プロジェクト管理、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）
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, project management, 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)
Education
- 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。
- Language Skills (he/she is able to read and write English)
- He/she has an ability to write the business documents
Experience
- 医療機器の薬事申請における３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
- 当局（PMDA/MHLW）との相談事項の立案、実行の経験があれば望ましい
- 医用電気機器に関する知識・経験があれば望ましい
- 3+ years of experience of medical device application approvals
- Good communications skills and project management skills
- Preferred if he/she has an experience of having PMDA/MHLW consultation meeting
- Preferred if he/she has knowledge/experience in Medical electrical equipment
Competencies
- 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
- 新しいことに挑戦する意欲を持った人材
- 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.
- He/she needs to have a challenge to inexperienced things
Skills Required
- Approximately 3 years of practical experience with medical device regulatory approval applications
- Ability to read and write English
- Business document writing skills
- Strong communication skills
- Project management skills
- Experience planning and conducting consultations with PMDA or MHLW
- Knowledge or experience with medical electrical equipment
- Ability to communicate effectively with internal departments
- Integrity and an action-oriented mindset
- Willingness to take on unfamiliar challenges
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
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Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
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Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.
Stryker Insights
What We Do
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 www.stryker.com. Together with our customers, we are driven to make healthcare better.
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