Regulatory Specialist – AI/ML Projects

Clarius Mobile Health

Regulatory Specialist supporting AI/ML medical-device strategies and submissions at Clarius Mobile Health, an affordable connected-ultrasound company. Creating DHF, model-validation, data, and compliance documentation for Canada, FDA, and EU pathways.

Posted 8/11/2026contractRemote • 🇨🇦 CanadaMid-LevelSenior💰 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 the creation of regulatory submissions and technical documentation. Proficient in navigating complex regulatory requirements and collaborating with cross-functional teams to ensure compliance and quality management.

Highest-signal resume keywords

Regulatory SubmissionsAI/ML Product ExperienceISO 13485 KnowledgeFDA 510(k) DocumentationQuality Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationDesign History File (DHF)Machine Learning ConceptsModel Verification and ValidationData PreparationPerformance Metrics DocumentationTechnical WritingRegulatory Strategy ExecutionVersion ControlChange Management

Soft Skills

Attention to DetailTime ManagementAnalytical SkillsCollaborationSelf-Motivation

Industry Keywords

MedtechAI/ML-Enabled Medical DevicesIEC 62304ISO 14971IEC 62366MDSAPEU MDRHealth Canada RegulationsClinical Study RequirementsRegulatory Processes

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
Collaborate with ML engineers and Regulatory Affairs to define and execute AI/ML product regulatory strategies
Document ML algorithms, datasets, and performance metrics for regulatory review
Create technical documentation covering model training methodologies, data preparation, and model verification and validation
Write technical sections of FDA 510(k), Health Canada, and EU MDR submissions with the Regulatory Affairs team
Support regulatory technical documentation and DHF documentation requirements
Maintain version control and document change management

Requirements

What you’ll need

Post-secondary education in a scientific or technical field or equivalent experience
5+ years of experience in a regulated industry, such as Medtech, with direct experience on AI/ML-enabled products and regulatory submissions
Interest in ML concepts and processes related to designing and developing 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 approach
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 R&D, Data Science, and Regulatory Affairs teams
Knowledge of clinical study requirements and regulatory processes, including IDEs, ITAs, and IRB

Benefits

Comp & perks

High-impact project contributing to more affordable ultrasound and more accessible medical imaging
Three-Time Certified Great Place to Work environment
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