Traferox creates, manufactures, and commercializes products used to transplant solid organs (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox currently sells the TorEx Lung Perfusion System and the X°Port Lung Transport Device. Traferox Technologies is committed to improving the outcomes of organ transplants and to saving patients’ lives.

Traferox Technologies Inc.

Position Summary:

The Regulatory Affairs Specialist is responsible for supporting and maintaining regulatory compliance for medical devices across global markets, including Canada, the United States, the European Union, and other regulated jurisdictions. This role prepares and manages regulatory submissions, maintains product and facility licenses and registrations,



supports responses to regulatory authorities, and ensures ongoing compliance with applicable regulations and quality standards such as ISO 13485, MDSAP, EU MDR, and FDA requirements.

The incumbent will also contribute to post-market surveillance activities, complaint assessment and adverse event reporting, regulatory impact assessments for product changes, and audit support. Working closely with cross-functional teams, the Regulatory Affairs Specialist helps ensure that products remain compliant throughout their lifecycle while supporting the organization's quality and regulatory objectiv

Duties and Responsibilities:

📌 Regulatory Affairs Specialist Toronto
🏢 University Health Network
📍 Toronto