Regulatory Affairs Specialist – Medical Devices (EMEA)

Nipro Europe Group Companies

Mechelen

Sur place

EUR 55 000 - 85 000

Plein temps

14 jours+

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Résumé du poste

Nipro Europe Group Companies, based at the Mechelen, Belgium headquarters, is seeking a hands-on Regulatory Affairs Specialist for the RAQACA team. You will manage regulatory activities for medical devices and IVDs across Europe, Africa, India, and the Americas, coordinating registrations and lifecycle management with internal and external stakeholders.

The role emphasizes collaboration, regulatory intelligence, and process improvement to ensure timely authorizations and continued compliance.

Qualifications

Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy or Regulatory Affairs.
Experience in Regulatory Affairs within medical devices is preferred.
Knowledge of medical device regulations and registration processes.
Experience with regulatory submissions or lifecycle management across international markets.
Strong project coordination and deadline management.

Responsabilités

Coordinate national registration activities for MNE territories.
Interact with internal/external stakeholders for registration dossiers and timelines.
Maintain PVNC/VNC documents and certificates; update Belgian authorities.
Provide regulatory intelligence and guidance to internal teams.
Support continuous improvement of RA processes and cross-functional collaboration.