processes, and a proactive approach to evolving regulations (FDA MLMD guidance, EU AI Act, MDR, ISO/IEC standards).
Key Responsibilities
• Develop and implement global regulatory strategies for AI‑based medicaldevices and integrated software/hardware...
Sterilized MedicalDevices - Requirements for Materials, Sterile Barrier Systems and Packaging Systems).
• Working knowledge of ISO 11607-2 (Packaging for Terminally Sterilized MedicalDevices - Validation Requirements for Forming, Sealing and Assembly...
strategy to post-market management.
The ideal candidate will manage a regulatory team, develop regulatory strategies, and engage with international regulatory bodies to secure timely approvals and market access for innovative medicaldevices.
#J-18808...
apartmentCOSMED - The Metabolic CompanyplaceViterboevent_available
We are looking for a cybersecurity specialist to join our R&D team in Albano Laziale (Rome). The selected candidate will support the team in activities aimed at ensuring that COSMEDs medicaldevices are placed on and maintained in the market...
About us:
The physical and digital worlds are merging. Vehicles, medicaldevices, industrial systems, critical infrastructure: security hasn't kept pace. AI is accelerating everything, from the capabilities of the systems we depend on to the...
Sei pronto ad entrare in una realtà internazionale che sta ridefinendo gli standard dellindustria farmaceutica e dei MedicalDevices?
PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle oltre 40...
Ti piacerebbe lavorare in un contesto internazionale, su progetti sfidanti e ad alto valore nel settore Pharma e MedicalDevices, collaborando con clienti di primo piano in tutto il mondo?
PQE Group è una società di consulenza globale, attiva...
regolati (GxP, GMP, ISO per medicaldevices)
• Conoscenza di architetture IT/OT o integrazione dati
• Conoscenza generale delle tecnologie digitali per la manifattura (MES, sistemi data-driven, analytics, AI)
• Esperienza in progetti di digital...
About the role
We are looking for a Clinical Sales Specialist –Transcatheter Mitral & Tricuspid- Structural Heart to join our team in Italy. In this role, you will act as a trusted expert on structural heart therapies and medicaldevices...
Working knowledge of ISO 11607-1 (Packaging for Terminally Sterilized MedicalDevices - Requirements for Materials, Sterile Barrier Systems and Packaging Systems).
• Working knowledge of ISO 11607-2 (Packaging for Terminally Sterilized MedicalDevices...