At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.
Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for.
Department Info
The Regulatory Affairs (RA) Department at Terumo, based in Leuven, Belgium, ensures compliance with global regulatory standards and provides RA support services to internal and external stakeholders across the EMEA region.
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 templates
- Assist in the preparation of complex registration dossiers
- Support the distribution and follow-up of change notifications
- Help draft responses to regulatory authorities
- Assist in obtaining required documents and certificates
- Maintain the registration database and track approvals; communicate updates to Business Units and Sales
Labelling and Instructions for Use (IFUs)
- Coordinate translation and labelling review processes
- Prepare and maintain approved label and IFU copies
- Support 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 changes
- Support the organization and maintenance of external document records
General Administrative Support
- Maintain RA data in regulatory databases
- Assist 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 context
- Proficient in English (written and spoken); additional languages are a plus
- Comfortable with Microsoft Office, in particular Excel, and open to learning new software tools (SAP)
- Detail-oriented, well-organized, and a collaborative team player
Offer
At Terumo, you will contribute to improving healthcare and making a difference in patients’ lives. We provide:
A competitive salary and benefits package
A collaborative, respectful, and inclusive work environment
Opportunities for career growth and professional development
A 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.
Contact Person
Marjolein Buyl
Talent Acquisition Business Partner
Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.