Conseiller en IA et innovation numérique pour l’Université Canadienne de Kinshasa. Formation, mentorat et accompagnement de projets numériques à distance.
About the role
- Regulatory specialist guiding AI/ML medical-device strategies and submissions at Clarius, an AI-powered ultrasound company. Supporting FDA, Health Canada and EU regulatory documentation.
Responsibilities
- Collaborate with ML engineers and Regulatory Affairs teams to define and execute regulatory strategies for AI/ML products
- Maintain clear, detailed documentation of ML algorithms, datasets and performance metrics for regulatory review
- Create technical documentation covering AI/ML model training methodologies, data preparation procedures, and model verification and validation
- Collaborate with Regulatory Affairs on technical sections of FDA 510(k) and equivalent submissions, including Health Canada and EU MDR submissions
- Collaborate with Regulatory Affairs on regulatory technical documentation and DHF documentation requirements
- Maintain version control and document change management
- Translate complex machine learning concepts into clear, precise regulatory documentation
- Support Data Science and Regulatory Affairs teams in regulatory strategies for AI/ML-enabled medical devices
Requirements
- Post-secondary education in a scientific or technical field or equivalent experience
- 5+ years in a regulated medical device environment
- Hands-on ownership of pre-market submissions, including FDA 510(k) or equivalent, for AI/ML-enabled devices
- Hands-on experience designing or running prospective clinical studies for AI/ML devices, including IDE, ITA and IRB pathways
- Working knowledge of FDA guidance for AI/ML and SaMD, including CAD vs CDS classification
- Ability to lead regulatory strategy independently, with minimal guidance
- Working knowledge of ISO 13485, IEC 62304, ISO 14971, IEC 62366, MDSAP, EU MDR, FDA and Health Canada requirements for AI/ML-enabled devices
- Understanding of quality management systems and the software development lifecycle
- Working knowledge of ML concepts, including training, performance metrics and bias
- Experience working with data science and engineering teams
- Interest in ML concepts and processes related to the design and development of AI/ML-enabled medical devices
- Strategic, collaborative, analytical, focused and self-motivated
- Exceptional attention to detail and ability to work within strict documentation standards
- Strong time-management skills and ability to prioritize tasks in a fast-paced environment
- Strong verbal and written communication skills
- Ability to work effectively with cross-functional teams including R&D, Data Science and Regulatory Affairs
Benefits
- Two-year fixed-term contract
- Modern office with sit/stand desks
- Health and wellness facilities
- Stocked kitchen
- Outdoor amenities
- On-site daycare
- Enclosed parking
- Free on-site gym
- Close proximity to a SkyTrain station
- Great Place to Work-certified employer
- Employee well-being focus
- Equal opportunity employer
- Interview accommodations available upon request
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