Principal Regulatory Specialist – AI/ML Projects

🔥 4 minutes ago

🇨🇦 Canada – Remote

💵 $85k - $105k / year

⏳ Contract/Temporary

🔴 Lead

🤖 Artificial Intelligence

👻 Ghost score 0%

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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 • 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

• 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

• 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