ppAt Velferd, through our brand bVLF Consulting /b, we help medical device and healthcare companies bring innovative products to market safely, efficiently, and in compliance with international regulations. /ppOur team supports manufacturers worldwide in Regulatory Affairs, Quality Assurance, Clinical, and Technical Documentation, with a strong focus on bMedical Devices, SaMD, AI-based solutions, and Active Medical Devices /b. /ppWe are growing and looking for an experienced consultant who can contribute to challenging and high-impact projects in the MedTech sector. /ph3What You'll Do /h3pAs a bSoftware Active Medical Devices Consultant /b, you will work with international clients on the development, compliance, and market access of innovative medical technologies. /ppYour activities may include: /pulliSupporting software lifecycle processes according to bIEC 62304 /b /liliContributing to the development and compliance of active medical devices /liliPreparing and reviewing technical and regulatory documentation /liliPerforming gap assessments and compliance reviews /liliCollaborating with multidisciplinary design and development teams /liliSupporting cybersecurity and information security initiatives /liliProviding regulatory guidance for EU and US market access /liliParticipating in audits, inspections,



and technical reviews /li /ulh3What We're Looking For /h3h3Mandatory /h3pStrong experience in bmedical device software /b and/or bactive medical devices /b /ppSolid knowledge of: /pullibIEC 62304 /b /lilibIEC 60601 series /b /lilibEU MDR 2017/745 /b /lilibFDA regulatory framework /b /li /ulpAbility to work independently and manage client-facing activities /ppExcellent analytical and problem-solving skills /ppFluent English (written and spoken) /ppDegree in Computer Science, Biomedical Engineering, Electronic Engineering, or related disciplines /ph3Nice To Have /h3pExperience with: /pullibISO 27001 /b /liliCybersecurity for Medical Devices /liliSoftware Validation /liliArtificial Intelligence / Machine Learning in healthcare /liliIEC 81001-5-1 /liliFDA Cybersecurity Requirements /li /ulpPrevious consulting experience /ph3Why Join Us /h3ulliFlexible workload and project-based engagement /liliExposure to international MedTech projects /liliOpportunity to work with innovative technologies, including Software as a Medical Device (SaMD) and AI-driven solutions /liliDirect collaboration with senior regulatory and quality experts /liliDynamic and entrepreneurial environment where your contribution has real impact /li /ulh3Interested? /h3pIf you have experience in medical device software and want to work on projects that make a difference in healthcare, we'd like to hear from you. /ppbNote: Only applications that meet the required qualifications will be considered. /b /p /p #J-18808-Ljbffr

📌 Senior Software & SaMD Consultant (IEC 62304, MDR, FDA) | Freelance | Remote (Italia)
🏢 Velferd
📍 Italia