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 accurate regulatory materials and executing strategies for AI/ML-enabled medical devices. Strong 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.
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📌 Regulatory Specialist for AI/ML Devices (New Brunswick)
🏢 Clarius Mobile Health
📍 New Brunswick