About the role

Regulatory Specialist advancing AI/ML medical-device strategies and submissions for Clarius’s affordable cloud-connected ultrasound technology. Documenting models, datasets, validation, and FDA, Health Canada, and EU MDR requirements.

Responsibilities

Support Data Science and Regulatory Affairs teams in defining and executing regulatory strategies for AI/ML-enabled medical devices
Translate complex machine learning concepts into clear, precise regulatory documentation
Create design history file (DHF) documentation
Prepare regulatory submissions and related data documentation
Maintain detailed documentation of ML algorithms, datasets, and performance metrics for regulatory review
Create technical documentation covering AI/ML model training methodologies and data preparation procedures
Create model verification and validation documentation
Collaborate with Regulatory Affairs on technical sections of FDA 510(k) and equivalent Health Canada and EU MDR submissions
Collaborate on regulatory technical documentation and DHF requirements
Maintain version control and document change management
Work with ML engineers, R&D, Data Science, and Regulatory Affairs teams

Post-secondary education in a scientific or technical field or equivalent experience
5+ years of experience in a regulated medical device environment or regulated industry
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
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
Knowledge of ML concepts, including training, performance metrics, and bias
Interest in ML concepts and processes related to AI/ML-enabled medical device design and development
Experience working with data science and engineering teams
Ability to lead regulatory strategy independently with minimal guidance
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