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About the Role

Support Data Science and Regulatory Affairs teams in defining and executing regulatory strategies for AI/ML-enabled medical devices. Responsibilities include translating complex machine learning concepts into clear, precise regulatory documentation, DHF creation, and regulatory submission preparation.

Responsibilities

• 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

Requirements

• 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
• Interest in ML concepts and processes related to the design & development of AI/ML-enabled medical devices
• 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
• Understanding of quality management systems and the software development lifecycle
• 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 communication skills (verbal and written) and ability to work effectively with cross-functional teams including R&D, Data Science, and Regulatory Affairs
• Knowledge of clinical study requirements and associated regulatory processes (i.e., IDEs, ITAs, IRB)

Skills

• AI/ML design and development methodologies
• SaMD requirements
• Software development lifecycle
• DHF creation
• Regulatory submission preparation
• Data documentation

Location

• Canada

Work Type

• Contract
• Fixed-term

Experience Level

• 5+ years

Education Level

• Post-secondary education in a scientific or technical field or equivalent experience

Salary/Compensations

• $85,000-$105,000

Benefits

• Modern office with sit/stand desks
• Health & wellness facilities
• Stocked kitchen
• Outdoor amenities
• On-site daycare
• Enclosed parking
• Free on-site gym
• Proximity to SkyTrain station

About the Company

• Clarius is on a mission to make medical imaging accessible everywhere by delivering high-performance, affordable, and easy-to-use solutions powered by artificial intelligence and connected to the cloud.
• The team consists of 140+ talented, innovative, and highly collaborative individuals.
• The company is a thrice-certified Great Place to Work.

Equal Opportunity

• Clarius Mobile Health is proud to be an Equal Opportunity Employer. We encourage applications from any qualified candidate regardless of ethnicity, religion, age, national origin, disability status, sexual orientation, gender identity or expression. Please let us know if you require any accommodations during the interview process.