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Job Description

職務内容 :

医療機器、体外診断用医薬品、動物用医薬品、研究用試薬（消耗品、機器含む）に係る薬事対応業務

・製造販売業の維持・管理（更新申請手続き等、3役会議事務局運営など）

・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理

・QMS適合性調査申請（承認前調査/定期調査）

・外国製造業者認定・登録の維持・管理

・QMS内部監査対応（被監査部門への監査の実施、報告書作成保管等 1回/年）

・GVP対応（情報収集、当局報告、記録書作成保管等）

・薬事トレーニングの実施管理（年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等）

・プロモーションマテリアルレビューの管理

・海外拠点及び顧客からの問合せ対応

必要とされる資格・経験

・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験（1年以上）

・薬事規制（特に安全管理業務）に関する知識

・当局対応経験　

・海外とコミュニケーションを行う英語力（メール対応）

・基本的なPCスキル（Word、Excel（表計算・グラフ作成）、PowerPoint）

歓迎される資格・経験

・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験

・安全性に関わる業務経験

・ドキュメント管理システムの使用経験

・製造販売業の三役の経験

Thermo Fisher Scientific Inc. is seeking a highly motivated individual to join our world-class team as a Regulatory Affairs Specialist II in Japan. As a global leader in scientific research, we are dedicated to making the world healthier, cleaner, and safer.

Responsibilities:

• Work with RA/QA team to maintain and handle regulatory licenses of IVD/MD/AH (MAH, FMA, etc.) under the PMD Act and perform QMS activities.

• Responsible for GVP operations for Medical Device (MD) /IVD products/ Animal Health products(AH) in Life Technologies Japan.

• Collaborate with cross functional discussion and issue management and close collaboration with Internal Stakeholders such as business teams, internal RAQA team, SCM and other related teams for GVP operation

• Running the implementation of regulatory training (drafting annual plans, crafting training materials, implementing e-learning, crafting and storing records, etc.)

• Management of promotional material reviews

• Responding to inquiries from overseas bases and customers

Required qualifications and experience:

• Minimum 1 year of experience in RAQA within the pharmaceuticals, medical devices, or in vitro diagnostics industry

• Knowledge of Japanese regulatory requirements

• English skills to connect with overseas parties (email correspondence)

• Basic PC skills (Word, Excel (spreadsheets and graphs), PowerPoint)

Qualifications and experience encouraged

• Experience responding to QMS conformity surveys and ISO13485 surveys by regulatory authorities or certification registration bodies

• Experience in safety-related work

• Experience using document management systems

• Experience in the three roles of a manufacturing and sales company

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.