Regulatory Specialist – AI/ML Projects

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Specialist – AI/ML Projects based in Canada.

This is a specialized regulatory role supporting the development and commercialization of AI/ML-enabled medical devices. You will work at the intersection of regulatory affairs, data science, machine learning, and medical device development. Your expertise will help translate complex AI/ML methodologies into clear, accurate, and audit-ready regulatory documentation. You will contribute to regulatory strategies and submissions across major markets, including Canada, the United States, and Europe. The role offers the opportunity to influence how innovative medical imaging technologies progress through development and regulatory review. This is a highly collaborative environment where precision, scientific understanding, and strong documentation practices are essential.