31 ago - Pisa
Vlf Consulting
pbAbout VLF Consulting /b /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. /ppbr/ppbWhat You'll Do /b /ppAs 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 /liliSupporting risk management activities /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 /ulpbr/ppbWhat We're Looking For /b /ppbMandatory /b /ppStrong 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 /ppbr/ppbNice To Have /b /ppExperience 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 /ppbr/ppbWhy Join Us /b /pulli100% remote collaboration /liliFlexible 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 /ulpbr/ppbInterested? /b /ppIf 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. /ppbr/ppbNote: Only applications that meet the required qualifications will be considered. /b /p
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