11 set - Roma
Velferd
At 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 Do As 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 62304
Contributing to the development and compliance of active medical devices
Preparing and reviewing technical and regulatory documentation
Performing gap assessments and compliance reviews
Collaborating with multidisciplinary design and development teams
Supporting cybersecurity and information security initiatives
Providing regulatory guidance for EU and US market access
Participating in audits, inspections, and technical reviews
What We're Looking For Mandatory Strong experience in medical device software and/or active medical devices
Solid knowledge of:
IEC 62304
IEC 60601 series
EU MDR 2017/745
FDA regulatory framework
Ability to work independently and manage client-facing activities
Excellent analytical and problem-solving skills
Fluent English (written and spoken)
Degree in Computer Science, Biomedical Engineering, Electronic Engineering, or related disciplines
Nice To Have Experience with:
ISO 27001
Cybersecurity for Medical Devices
Software Validation
Artificial Intelligence / Machine Learning in healthcare
IEC 81001-5-1
FDA Cybersecurity Requirements
Previous consulting experience
Why Join Us Flexible workload and project-based eng
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