Regulatory Specialist – AI/ML Projects

📋 Description

• Collaborate with machine learning engineers and Regulatory Affairs teams to define and execute
• Translate complex ML concepts into clear regulatory documentation.
• Maintain documentation covering ML algorithms, datasets, model performance metrics, training
• Develop and maintain technical documentation related to AI/ML model verification and validation.
• Support FDA 510(k) submissions and regulatory submissions in Canada and Europe.
• Work cross-functionally to ensure regulatory requirements are integrated into product development.

🎯 Requirements

• Post-secondary education in a scientific/technical discipline or equivalent experience.
• At least 5 years in a regulated industry, preferably medical technology, with AI/ML regulatory
• Strong understanding of ISO 13485, IEC 62304, ISO 14971, IEC 62366, MDSAP, EU MDR, FDA, and Health
• Experience preparing regulatory/technical documentation for software or medical devices.
• Knowledge of clinical study requirements, IDEs, ITAs, and IRB processes.
• Excellent written/verbal communication and cross-functional collaboration skills.

🎁 Benefits

• Salary range of $85,000–$105,000 CAD.
• Two-year fixed-term contract.
• Remote opportunity open to candidates across Canada.
• Opportunity to work on AI/ML-enabled medical imaging technology.
• Collaborative, cross-functional environment with access to regulatory, data science, and R&D
• Modern workplace facilities with on-site amenities and accessible transportation.