Company Description

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.

Job Description

Work Location: 2400 Skymark Ave., Unit 3, Mississauga, ON

Department: Quality and Regulatory

Reports to: Regulatory Affairs Manager

Work Model: On-site

Status: Permanent Full-time

Closing date: November 13, 2025

Duties and Responsibilities:

• Prepare technical documents to support market-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
• Maintain regulatory files for EU, US, Canada, and other regulated markets, ensuring that files are updated to reflect current products and standards.
• Maintain company facility and product licenses and registrations in all active jurisdictions including renewals, device listings, site registrations, supplements for changes and annual reports.
• Assist in preparing responses to regulatory authorities’ questions within assigned timelines.
• Stay abreast of updates to regulations and standards. Perform gap analyses and make required changes in Traferox procedures as required. Maintain procedures in compliance with ISO 13485 and MDSAP requirements.
• Assess device related complaints for medical device reporting requirements. Assist with preparation of country-specific forms for reportable incidents within the required timeline.
• Participate in any required regulatory notices, recalls and field actions, if required.
• Maintain product UDI listings in country-specific databases.
• Assist in internal and external audits, providing regulatory input as needed, and participate in writing and executing corrective action plans for audit nonconformances.
• Assess and document regulatory impact of product design changes in jurisdictions where product is licensed.
• Participate in post-market surveillance activities for licensed products.

Qualifications

Education:

• Bachelor of Science Degree (or equivalent).
• Post-Graduate Degree or Certificate in Regulatory Affairs, or equivalent work experience.

Experience:

• 3+ years’ experience in medical device or biologics regulatory affairs.

Skills and Knowledge:

• Familiarity with medical device standards and regulations such as ISO 13485, ISO 14971, EU MDR, US FDA 21CFR, Canada SOR 98/282.
• Excellent written and verbal skills.
• Excellent organization and file management skills.
• Proficient with Microsoft office products.
• Adaptable, able to work both independently and with high performance teams.
• Ability to consume and understand technical and clinical information to support regulatory filings and summaries.
• Exposure to complaint handling and adverse event reporting is an advantage.