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Job Description & How to Apply Below
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
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