Regulatory Affairs Consultant (SaMD)

Location: Brussels, Belgium (1-2 days per week on site)

Start Date: Ideally ASAP

Contact: 12 months (freelance engagement)

About the Role

We're looking for an experienced consultant to advise on regulatory and quality strategies for software-driven medical technologies. This role is ideal for someone who understands the complexities of compliance for digital health solutions and can guide clients through the entire product lifecycle-from concept to market approval.

What You'll Do

• Partner with clients to determine compliance pathways for software-based medical products, including diagnostic, therapeutic, monitoring, and decision-support applications.
• Review development plans, technical documentation, risk files, and validation protocols to ensure alignment with global standards (FDA, IEC 62304, ISO 13485).
• Advise on building and maintaining quality systems tailored to software medical devices, including lifecycle processes, configuration control, and verification/validation activities.
• Support preparation of regulatory submissions for U.S. and international markets (e.g., 510(k), de novo, PMA).
• Conduct gap analyses on development workflows and quality systems to identify compliance risks and improvement opportunities.
• Collaborate with engineering, QA, regulatory, and clinical teams to embed regulatory requirements throughout development.
• Assist with regulatory communications, including meetings and responses to authorities or notified bodies.

What We're Looking For

• 5+ years in regulatory affairs, QA, or software development within the medical device sector, with hands-on experience in SaMD compliance.
• Deep knowledge of FDA regulations and relevant standards (IEC 62304, ISO 13485).
• Proven success in bringing software-based medical products to market, including apps and cloud-based solutions.