RA officer

Role Summary

Responsible for regulatory and quality activities for Class I & II medical devices, ensuring compliance with EU MDR, CE, and ISO 13485 requirements.

Key Responsibilities

• Manage and maintain regulatory data (EUDAMED, MoH portals, internal systems).

• Review regulatory and technical documentation for CE/MDR compliance.

• Verify CE, ISO, and related certificates.

• Perform supplier/manufacturer qualification and desktop evaluations.

• Support QMS activities, SOP development, and document approvals.

• Coordinate with manufacturers and internal teams on product-related issues.

Qualifications

• Bachelor’s/Master’s in Life Sciences, Regulatory Affairs, or Biomedical Engineering.

• 3–5 years of RA/QA experience in medical devices (Class I & II).

• Strong knowledge of EU MDR, ISO 13485, CE marking.

• Excellent English communication skills; MS Office proficiency.

• Italian language knowledge is a plu