Remote MedTech SaMD & Active Devices Consultant

VLF Consulting; Savona; Remoto; EUR 60.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote collaboration

Flexible projects

International exposure

SaMD/AI focus

Senior collaboration

Impactful work

Descrizione del lavoro

VLF Consulting (Velferd brand) seeks an experienced Software & Active Medical Devices Consultant to work with international clients on the development, compliance, and market access of innovative medical technologies.

You will contribute to software lifecycle processes per IEC 62304, support regulatory reviews for EU MDR and FDA, and collaborate with cross-functional teams while working remotely on diverse MedTech projects.

Competenze

• Strong experience in medical device software and/or active medical devices.
• Solid knowledge of IEC 62304, IEC 60601 series, EU MDR 2017/745 and 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.

Mansioni

• Work with international clients on development, compliance, and market access of medical technologies.
• Support software lifecycle processes according to IEC 62304.
• Prepare and review technical and regulatory documentation.
• Perform gap assessments and compliance reviews.
• Support risk management activities.
• 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

Fluent English

independent work

analytical problem solving

Formazione

Degree in Computer Science / Biomedical Engineering / Electronic Engineering

Descrizione del lavoro

VLF Consulting (Velferd brand) seeks an experienced Software & Active Medical Devices Consultant to work with international clients on the development, compliance, and market access of innovative medical technologies.

You will contribute to software lifecycle processes per IEC 62304, support regulatory reviews for EU MDR and FDA, and collaborate with cross-functional teams while working remotely on diverse MedTech projects.