Elevate your career with Clarius as an AI Regulatory Specialist, focusing on medical devices. Your expertise will drive impactful regulatory documentation for enhanced patient care.

In this two-year fixed-term contract, you'll be integral to the Data Science and Regulatory Affairs teams. Your key responsibilities will include executing regulatory strategies, translating machine learning concepts into clear documentation, and overseeing regulatory submissions for AI/ML-enabled medical devices. Your role is critical in ensuring compliance and effectiveness in the development processes.

Key Responsibilities:
• Define regulatory strategies with ML engineering and RA teams
• Document ML algorithms and performance for regulatory reviews




• Generate technical documentation for AI/ML methodologies
• Assist in writing technical segments for regulatory submissions
• Implement version control and documentation changes

Requirements:
• Minimum 5 years in regulated sectors (Medtech)
• Knowledge of ISO, IEC, and FDA guidelines
• Educational background in scientific or technical fields
• Strong analytical and team-oriented skills
• Acute attention to detail for compliance

Apply your skills at Clarius to transform medical imaging through innovation and regulatory excellence.
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📌 AI Regulatory Specialist at Clarius (New Brunswick)
🏢 Clarius Mobile Health
📍 New Brunswick