Senior Software & Samd Consultant (Iec 62304, Mdr, Fda) | Freelance | Remote
Pubblicato il 29-08-2026 - Vlf Consulting in San Rocco al Porto
About VLF ConsultingAt Velferd, through our brand VLF Consulting, we help medical device and healthcare companies bring innovative products to market safely, efficiently, and in compliance with international regulations.Our team supports manufacturers worldwide in Regulatory Affairs, Quality Assurance, Clinical, and Technical Documentation, with a strong focus on Medical Devices, SaMD, AI-based solutions, and Active Medical Devices.We are growing and looking for an experienced consultant who can contribute to challenging and high-impact projects in the MedTech sector.What You'll DoAs a Software & Active Medical Devices Consultant, you will work with international clients on the development, compliance, and market access of innovative medical technologies.Your activities may include:Supporting software lifecycle processes according to IEC 62304Contributing to the development and compliance of active medical devicesPreparing and reviewing technical and regulatory documentationPerforming gap assessments and compliance reviewsSupporting risk management activitiesCollaborating with multidisciplinary design and development teamsSupporting cybersecurity and information security initiativesProviding regulatory guidance for EU and US market accessParticipating in audits, inspections,
and technical reviewsWhat We're Looking ForMandatoryStrong experience in medical device software and/or active medical devicesSolid knowledge of:IEC 62304IEC 60601 seriesEU MDR 2017/745FDA regulatory frameworkAbility to work independently and manage client-facing activitiesExcellent analytical and problem-solving skillsFluent English (written and spoken)Degree in Computer Science, Biomedical Engineering, Electronic Engineering, or related disciplinesNice To HaveExperience with:ISO 27001Cybersecurity for Medical DevicesSoftware ValidationArtificial Intelligence / Machine Learning in healthcareIEC 81001-5-1FDA Cybersecurity RequirementsPrevious consulting experienceWhy Join Us100% remote collaborationFlexible workload and project-based engagementExposure to international MedTech projectsOpportunity to work with innovative technologies, including Software as a Medical Device (SaMD) and AI-driven solutionsDirect collaboration with senior regulatory and quality expertsDynamic and entrepreneurial environment where your contribution has real impactInterested?If 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.Note: Only applications that meet the required qualifications will be considered.