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As a medical device manufacturer, Circle Cardiovascular Imaging Inc. (Circle) operates within a regulated industry and must maintain a robust Quality Management System (QMS) to support global market access and lifecycle compliance. As the organization expands and maintains its regulatory footprint across multiple jurisdictions, the volume and complexity of jurisdiction-specific regulatory compliance requires in-depth intelligence, such as submission pathways, classification rules, reporting timelines, and any unique regulations. With regulatory frameworks evolving globally, maintaining a structured, current, and accessible regulatory intelligence index has become an increasingly strategic priority for the RA/QMS team.
The improvement priority addressed by this project is the gathering, consolidation, and enhancement of Circle’s regulatory intelligence framework to better support global expansion, compliance activities, and cross-functional decision-making. This project focuses on foundational infrastructure improvements that strengthen long-term efficiency, consistency, and knowledge management. In addition, this project requires applied expertise in regulatory affairs, quality systems, and an understanding of medical device regulations on the global stage, combined with strong research and analytical skills to interpret these regulations and translate them into structured outputs.
Zenobia Ali
Circle Cardiovascular Imaging
Life Sciences
Professional, scientific and technical services
University of Calgary
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