Senior Software & SaMD Consultant (IEC 62304, MDR, FDA) | Freelance | Remote

About VLF Consulting

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.