regulatory affairs specialist (ra) / ~8m jpy @ global medtech.

社名
社名非公開

職種
薬事、メディカルライティング

業務内容
Work as a Legal Manufacturer RA, driving global market access directly from Japan.
Join a top-tier global healthcare leader with a stable, inclusive, and professional environment.
Engage in cross-border projects using English daily within a dynamic factory RA team.

求められる経験
■Requirements
・Strong English and Japanese communication skills (written and verbal)
・Experience in Regulatory Affairs for IVD or Medical Devices; typically 2+ years
preferred, but equivalent experience considered
・Ability to collaborate effectively with cross-functional teams
・Understanding of regulatory requirements for IVD/Medical Devices
・Basic understanding of ISO 13485 and global QMS principles
・High attention to detail and strong documentation management skills

■Nice to haves
・Experience in building and maintaining Technical Files (e.g., IVDR, CSDT, STED)
・Hands-on experience with international product registrations and change submissions
・Project coordination or cross-functional collaboration experience
・Familiarity with risk management principles (ISO 14971) ...