EMEA Regulatory Affairs Officer – Medical Devices

Terumo Europe NV; Leuven; Presencial; EUR 55 000 - 75 000; Tempo integral

Resumo da oferta

Terumo Europe NV in Leuven, Belgium, seeks a Regulatory Affairs Officer to ensure medical devices meet European, Middle Eastern and African regulatory requirements. The role reports to the Regulatory Affairs Director and involves managing product registrations, labeling reviews, and staying updated on regulatory changes across EMEA.

The candidate should have a science degree, strong English skills, and the ability to collaborate across departments.

Qualificações

• Experience or knowledge of regulatory requirements for medical devices and pharmaceuticals is an asset.
• Excellent written and spoken English.
• Dutch language knowledge is an advantage.
• Accurate, organized, and able to multitask in a cross-functional team.

Responsabilidades

• Prepare and maintain product registration files.
• Review labelling and promotional material for regulatory compliance.
• Ensure multilingual product labeling and instructions comply with regulations.
• Monitor regulatory developments across EMEA and support new systems implementations.
• Provide regulatory information for tender processes and customer inquiries.

Conhecimentos

Regulatory affairs

English proficiency

Communication skills

Multitasking

Formação académica

Science degree

Descrição da oferta de emprego

Terumo Europe NV in Leuven, Belgium, seeks a Regulatory Affairs Officer to ensure medical devices meet European, Middle Eastern and African regulatory requirements. The role reports to the Regulatory Affairs Director and involves managing product registrations, labeling reviews, and staying updated on regulatory changes across EMEA.

The candidate should have a science degree, strong English skills, and the ability to collaborate across departments.