Senior SaMD & MedTech Software Consultant

Velferd srl; Italia; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Velferd srl, through its brand VLF Consulting, is seeking a Software & Active Medical Devices Consultant to work with international clients on development, regulatory compliance, and market access of medical technologies.

You will contribute to software lifecycle processes according to IEC 62304, support active medical devices, prepare and review regulatory documentation, and participate in audits and inspections. Fluent English and a relevant degree are required.

Competenze

• Strong experience in medical device software and/or active medical devices.
• Solid knowledge of IEC 62304, IEC 60601, EU MDR 2017/745 and FDA regulatory framework.
• Ability to work independently and manage client-facing activities.
• Fluent English (written and spoken).

Mansioni

• Support software lifecycle processes according to IEC 62304.
• Contribute to the development and compliance of active medical devices.
• Prepare and review technical and regulatory documentation.
• Perform gap assessments and compliance reviews.
• Collaborate with multidisciplinary design and development teams.
• Support cybersecurity and information security initiatives.
• Provide regulatory guidance for EU and US market access.
• Participate in audits, inspections, and technical reviews.

Conoscenze

Medical device software

Active medical devices

Regulatory affairs

Independent client-facing work

Formazione

Computer Science

Biomedical Engineering

Strumenti

IEC 62304

IEC 60601

EU MDR 2017/745

FDA regulatory framework

ISO 27001

Cybersecurity for Medical Devices

Descrizione del lavoro

Velferd srl, through its brand VLF Consulting, is seeking a Software & Active Medical Devices Consultant to work with international clients on development, regulatory compliance, and market access of medical technologies.

You will contribute to software lifecycle processes according to IEC 62304, support active medical devices, prepare and review regulatory documentation, and participate in audits and inspections. Fluent English and a relevant degree are required.