Associate Manager, Regulatory Affairs

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid or Onsite

The Jobs 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.

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PMDANB 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
Experience of PMDA consultation and application approvals of improved device (preferably Class IV)
Good communications skills and project management skills
医療機器クラスＩＩＶの薬事申請における最低6年程度の実務経験
PMDA相談経験及び改良医療機器クラスＩＶであれば望ましいの薬事申請経験
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

Travel Percentage: None

Required Experience:

Manager

Work Flexibility: Hybrid or OnsiteThe Jobs MissionUnder 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.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 A...

Work Flexibility: Hybrid or Onsite

The Jobs 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.

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PMDANB 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
Experience of PMDA consultation and application approvals of improved device (preferably Class IV)
Good communications skills and project management skills
医療機器クラスＩＩＶの薬事申請における最低6年程度の実務経験
PMDA相談経験及び改良医療機器クラスＩＶであれば望ましいの薬事申請経験
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

Travel Percentage: None

Required Experience:

Manager

Key Skills

Proofreading
Adobe Acrobat
FDA Regulations
Manufacturing & Controls
Biotechnology
Clinical Trials
Research & Development
GLP
cGMP
Product Development
Chemistry
Writing Skills

Apply Now

About Company

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. Alongsid ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click