Job Summary As a member of the RA Department, you are primarily responsible for assisting the RA Officer and RA Director on dossiers for Terumo Cardiovascular Systems, and supporting other stakeholders in their daily operations. Job Responsibilities Product registration Prepare routine registration files using existing templatesAssist in the preparation of complex registration dossiersSupport the distribution and follow-up of change notifications Help draft responses to regulatory authoritiesAssist in obtaining required documents and certificatesMaintain the registration database and track approvals; communicate updates to Business Units and Sales Labelling and Instructions for Use (IFUs) Coordinate translation and labelling review processesPrepare and maintain approved label and IFU copiesSupport ad hoc review of promotional materials Document Control and QMP Support Act as masterfile coordinator in the electronic documentation system; update document properties following organizational changesSupport the organization and maintenance of external document records General Administrative Support Maintain RA data in regulatory databasesAssist with listing requests in the ERP system (SAP)Provide general administrative support: document formatting, literature searches, meeting arrangements Support the Clinical & Vigilance team with ad hoc document preparation Profile Description Master’s or Bachelor’s degree in Legal Studies, Business Administration, or Sciences, with a strong interest in administrative tasks; or equivalent experience in dossier management, preferably in a regulatory or legal contextProficient in English (written and spoken); additional languages are a plusComfortable with Microsoft Office, in particular Excel, and open to learning new software tools (SAP)Detail-oriented, well-organized, and a collaborative team playerOffer At Terumo, you will contribute to improving healthcare and making a difference in patients’ lives. We provide: A competitive salary and benefits packageA collaborative, respectful, and inclusive work environmentOpportunities for career growth and professional developmentA chance to work with a high-performing, passionate team During the recruitment process, you will have the opportunity to meet with the hiring manager, and other dedicated Terumo associates.