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