About VLF Consulting

Per essere preso/a in considerazione per un colloquio, la preghiamo di assicurarsi che la sua candidatura sia pienamente in linea con le specifiche del lavoro riportate di seguito.

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

Supporting risk management activities

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

100% remote collaboration

Flexible workload and project-based engagement

Exposure to international MedTech projects

Opportunity to work with innovative technologies, including Software as a Medical Device (SaMD) and AI-driven solutions

Direct collaboration with senior regulatory and quality experts

Dynamic and entrepreneurial environment where your contribution has real impact

Interested?

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. xkiyazw

Per questa posizione sono disponibili opzioni di lavoro a distanza/a casa.

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