Regulatory Specialist – AI/ML Projects

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Clarius Mobile Health

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

💰 $6.3M Venture Round on 2018-05

Manufacturing • Healthcare • Biotechnology

Clarius Mobile Health is on a mission to make accurate, easy-to-use, and affordable ultrasound tools available to all medical professionals. The company specializes in handheld wireless ultrasound scanners that connect to iOS and Android devices, providing high-resolution ultrasound images typically associated with larger, more expensive systems. Since introducing its first portable scanner in 2016, Clarius has enabled over half a million scans performed by 20,000 users across more than 50 countries, with its latest product, the Clarius HD, currently available in Canada, the United States, and Europe.

📋 Description

• 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

• 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

• 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