Regulatory Specialist (AI/Machine Learning Projects)

• This is a two-year fixed-term contract
• We’re seeking an experienced Regulatory Specialist to support our Data Science and Regulatory Affairs teams in defining and executing regulatory strategies for AI/ML-enabled medical devices
• You’ll need deep expertise in the regulatory landscape for AI/ML devices, including AI/ML design and development methodologies, SaMD requirements, and the software development lifecycle
• Over the next 24 months, your primary responsibilities will be translating complex machine learning concepts into clear, precise regulatory documentation including DHF creation, regulatory submission preparation, and related data documentation
• Collaborate with ML engineers and RA team 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, including AI/ML model training methodologies, data preparation procedures, and model verification and validation documentation
• Collaborate with RA team to write technical sections of FDA 510(k) and equivalent submissions (e.g., Health Canada, EU MDR)
• Collaborate with RA team on regulatory technical documentation and DHF documentation requirements
• Maintain version control and document change management

Benefits

• Competitive Benefits and Vacation
• Competitive Salary
• Commute/Home Office Allowance
• Flexible Hours & WFM
• Professional Development
• Volunteer Days- Strong time-management skills and ability to prioritize tasks in a fast-paced environment
• Strong communication skills (verbal and written) and ability to work effectively with cross-functional teams including R&D, Data Science, and Regulatory Affairs
• Understanding of quality management systems and the software development lifecycle
• Exceptional attention to detail and ability to work within strict documentation standards
• Working knowledge of ISO 13485, IEC 62304, ISO 14971, IEC 62366, MDSAP, EU MDR, FDA and Health Canada medical device regulatory requirements for AI/ML-enabled medical devices and SaMD
• Interest in ML concepts and processes related to the design & development of AI/ML-enabled medical devices
• Knowledge of clinical study requirements and associated regulatory processes (i.e., IDEs, ITAs, IRB)
• Post-secondary education in a scientific or technical field or equivalent experience
• 5+ years of experience in a regulated industry (e.g., Medtech) with direct experience working on AI/ML-enabled products and regulatory submissions
• Strategic, collaborative, analytical, focused, and self-motivated