Regulatory Affairs Support Specialist
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) Administrative & Technical Support Team is part of Terumo's Quality, Regulatory & Vigilance Department. This team is based in Leuven (Belgium), ensures complaince with global regulatory standards and provides RA support services to internal and external stakeholders across the EMEA region.
Job Summary
Our RA Administrative & Technical Support team is assisting our five business units. However, in this role, you will be primarily responsible for supporting the RA Officer and RA Director on dossiers for Terumo Cardiovascular Systems, while still assisting 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, we believe in offering more than just a job. It's an opportunity to make a difference, contribute to society through healthcare, and be a part of our passionate and high-performing team.
Rewards that match your dedication: We offer a competitive salary and benefits package that sets the benchmark for rewarding your commitment.
Join a passionate team: Become a valued member of our passionate and high-performing team where everyone is treated with respect. We are dedicated to creating a diverse, equal, and inclusive work environment.
Invest in your development: At Terumo, we invest in our associates by providing a wide range of development opportunities to help you grow both personally and professionally.
Work-life flexibility: Experience a hybrid way of working that balances office and home-based work to the fullest.
Connect with us: During the recruitment process, you'll have the opportunity to engage in meaningful conversations with the hiring manager and other enthusiastic 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.