Join Clarius as a Regulatory Specialist in the AI/ML medical device sector. You will support regulatory documentation and strategy execution to improve healthcare outcomes globally.

As a Regulatory Specialist, you will work on a fixed-term contract, supporting Clarius's Data Science and Regulatory Affairs teams. Your role includes translating advanced machine learning concepts into precise regulatory materials and executing strategies for AI/ML-enabled medical devices. Solid emphasis will be on regulatory submissions and maintaining detailed documentation throughout the software development lifecycle.

Key Responsibilities:



• Collaborate with ML engineers to define regulatory strategies • Manage documentation of algorithms and performance metrics • Create technical documentation for AI/ML processes • Prepare FDA 510(k) and equivalent submissions • Maintain version control and document change management

Requirements: • 5+ years in a regulated industry (Medtech) • Strong knowledge of ISO and FDA regulations • Tertiary education in scientific/technical field • Detail-oriented with exceptional documentation skills • Excellent communication and time-management abilities

Contribute your expertise in regulatory affairs to advance medical imaging accessibility with Clarius. #J-18808-Ljbffr

📌 Regulatory Specialist for AI/ML Devices (Winnipeg)
🏢 Clarius Mobile Health
📍 Winnipeg