Principal Regulatory Specialist – AI/ML Projects

Clarius Mobile Health

. Support Data Science and Regulatory Affairs teams in defining and executing regulatory strategies for AI/ML-enabled medical devices .

Posted 10/28/2026contractRemote • CanadaLead💰 CA$85,000 - CA$105,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategies for AI/ML-enabled medical devices, including hands-on experience with FDA 510(k) submissions and a strong understanding of relevant regulatory frameworks. Proficient in creating and maintaining comprehensive technical documentation and collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Regulatory Strategy DevelopmentFDA 510(k) Submission ExperienceISO 13485 KnowledgeMachine Learning Concepts UnderstandingTechnical Documentation Creation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsDesign History File DocumentationMachine Learning Algorithm DocumentationModel Verification and ValidationClinical Study DesignQuality Management SystemsPerformance Metrics AnalysisData Preparation ProceduresVersion ControlDocumentation Standards

Soft Skills

Attention to DetailTime ManagementAnalytical SkillsCollaborationCommunication Skills

Industry Keywords

AI/ML-Enabled Medical DevicesRegulated Medical Device EnvironmentFDA Guidance for AI/MLSaMDMDSAPEU MDRHealth Canada RequirementsIEC 62304ISO 14971IEC 62366

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Great Place to Work-certified employer
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
Equal opportunity employer
Interview accommodations available upon request