業務内容
◇職務内容(About the position)
診断薬・医療機器の設計開発責任者は,SHIONOGIが掲げる”Healthcare as a Service (HaaS)”と早期診断・早期治療 (“Test to Treat”) の実現のために,SHIONOGIがグローバルに展開する医薬品開発及びヘルスケアサービスに必要な各種診断薬・医療機器(特に核酸検査)の設計開発プロセスを統括し、品質・安全性・有効性を確保する責任を担う.
バイオマーカー、免疫測定法、分子診断技術に関する科学的知識を活用し、診断薬・医療機器のプロジェクトリーダーや品質保証、薬事、臨床チームと連携し、国内外の規制要件(薬機法、FDA、CEマーキング)や国際規格(ISO 13485、ISO 14971など),および品質マネジメントシステム(QMS)に準拠した設計管理を実施し,製品の上市に貢献する.
これらの業務を通じて,SHIONOGIが目指す最もよいヘルスケアソリューションのグローバル展開とヘルスケアの未来創出に貢献する.
The Diagnostics and Medical Device Design and Development Manager will be responsible for overseeing the design and development process for various diagnostics and medical devices (especially nucleic acid testing) required for SHIONOGI's global pharmaceutical development and healthcare services, ensuring their quality, safety, and efficacy, in order to realize SHIONOGI's ""Healthcare as a Service (HaaS)"" and early diagnosis and treatment (""Test to Treat"").
Utilizing scientific knowledge of biomarkers, immunoassays, and molecular diagnostic technologies, the Manager will collaborate with diagnostics and medical device project leaders and quality assurance, regulatory affairs, and clinical teams to implement design management in compliance with domestic and international regulatory requirements (Pharmaceutical and Medical Device Act, FDA, CE marking), international standards (ISO 13485, ISO 14971, etc.), and quality management systems (QMS), contributing to product launches.
Through these duties, the Manager will contribute to SHIONOGI's goal of providing the best healthcare solutions globally and creating the future of healthcare.