Regulatory Specialist – AI/ML Projects

Tasks

• Define regulatory strategies for AI ML medical devices
• Demonstrate compliance with medical device software quality risk usability requirements
• Develop technical documentation for ML verification and validation
• Maintain documentation for ML algorithms datasets model performance
• Manage document version control and change management
• Prepare FDA 510k submission sections
• Support clinical study regulatory documentation and processes
• Support regulatory documentation for Design History File
• Support regulatory submissions for Canada and Europe
• Translate machine learning concepts into regulatory documentation

Perks/Benefits

• Equal opportunity and accessibility
• Free on-site gym
• Health and wellness amenities
• Inclusive workplace
• On-site daycare
• Remote work opportunity

Skills/Tech-stack

Clinical Study Compliance | Clinical study | Design History File | Design history | Development Lifecycle | Device Software | EU MDR | FDA | Health Canada | IEC 62304 | IEC 62366 | IRB | ISO 13485 | ISO 14971 | MDSAP | Management System | Medical Device | Medical device software | Quality Management System | Quality management | Risk Management | Software Development Lifecycle | Software development | Usability Engineering | Verification and Validation