Quality/ Regulatory Affairs Specialist
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Location:
Bologna, Italy Type: Long Term Contract Must: Fluency in Italian Job Summary We are looking for a Regulatory Affairs & Certification Specialist to manage technical documentation, CE certification, and regulatory compliance for medical devices, particularly autoclaves. The candidate will ensure compliance with EU MDR regulations, applicable international standards, and quality requirements.
Key Responsibilities
• Prepare, review, and maintain Medical Device Technical Files.
• Ensure compliance with EU MDR 2017/745, IVDR (if applicable), and harmonized standards.
• Manage CE marking documentation and coordinate with Notified Bodies.
• Maintain documentation related to Risk Management (ISO 14971), Usability (IEC 62366), Medical Device Software (IEC 62304), and Electrical Safety/EMC (IEC 60601).
• Support PMS and PMCF activities.
• Coordinate regulatory activities with R&D, Quality, Clinical, and Production teams.
• Support audits, inspections, CAPA, and non-conformity management.
• Handle EUDAMED registration and support international regulatory submissions.
• Collaborate with Quality Assurance on ISO 13485, Change Control, and procedure updates. Must-Have Skills
• Medical Device Regulatory Affairs
• EU MDR 2017/745
• CE Marking and Technical Documentation
• Notified Body Coordination
• ISO 13485
• Risk Management – ISO 14971
• PMS / PMCF
• Good English communication skills
• MS Office and Adobe tools
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