Regulatory Specialist – AI/ML Projects
Tasks
- Collaborate with ML engineers and RA teams
- Create AI ML model training and data preparation documentation
- Create model verification and validation documentation
- Define and execute regulatory strategies for AI ML products
- Maintain documentation for ML algorithms datasets and performance metrics
- Manage version control and document change management
- Prepare regulatory and DHF documentation
- Write technical sections for FDA 510k and equivalent submissions
Perks/Benefits
- N/A
Skills/Tech-stack
Artificial Intelligence | Clinical Study Requirements | Clinical study | Development Lifecycle | Document Control | EU MDR | FDA | Health Canada | Health Canada regulations | IEC 62304 | IEC 62366 | ISO 13485 | ISO 14971 | MDSAP | Machine Learning | Management System | Medical Device | Medical device regulations | Quality Management System | Quality management | SaMD | Software Development Lifecycle | Software development
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Roles
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