Regulatory Affairs Specialist – Medical Devices (Europe)

Terumo Europe NV; Belgique; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Terumo Europe NV in Leuven, Belgium, seeks a Regulatory Affairs Officer to ensure medical devices meet EU/EMEA regulatory requirements. Reporting to the Regulatory Affairs Director, you will join a close-knit team navigating regulatory landscapes and maintaining product approvals.

Responsibilities include preparing and maintaining registration files, reviewing labelling and promotional material for compliance, and monitoring European regulations to support the business across EMEA.

Qualifications

• University degree in science or equivalent.
• Good working knowledge of English (written and spoken). Dutch is an advantage.

Responsabilités

• Prepare and maintain product registration files and technical documentation.
• Review labelling and promotional material for regulatory compliance.
• Monitor European medical device regulations and provide regulatory guidance across EMEA.

Connaissances

English proficiency

Multitasking

Communication skills

Detail oriented

Formation

Science degree

Description du poste

Terumo Europe NV in Leuven, Belgium, seeks a Regulatory Affairs Officer to ensure medical devices meet EU/EMEA regulatory requirements. Reporting to the Regulatory Affairs Director, you will join a close-knit team navigating regulatory landscapes and maintaining product approvals.

Responsibilities include preparing and maintaining registration files, reviewing labelling and promotional material for compliance, and monitoring European regulations to support the business across EMEA.