Regulatory Specialist at Clarius Group

Clarius is hiring a Regulatory Specialist for a two-year fixed-term contract to support its Data Science and Regulatory Affairs teams in developing regulatory strategies for AI/ML-enabled medical devices. The role focuses on translating machine learning concepts into regulatory documentation, including DHF creation, model and data documentation, FDA 510(k) and equivalent submissions, and change management. Candidates need post-secondary education in a scientific or technical field, at least five years of regulated-industry experience with AI/ML-enabled products and regulatory submissions, and knowledge of medical-device regulatory standards and software development lifecycle requirements. The position is open across Canada and pays $85,000-$105,000.