Senior Regulatory Affairs Specialist

Traferox creates, manufactures and commercializes products used for preservation, perfusion and assessment of solid organs (lungs, heart, liver, kidneys, pancreas).   These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox Technologies is committed to improving the outcomes of organ transplants and to saving patients’ lives.Location:The work will be performed in the company’s place of work at 2400 Skymark Ave. Unit 3, Mississauga, Ontario L4W 5K5. Minimal travel (< 10%) is expected.Traferox Technologies Inc. Union: Non-Union Number of Vacancies: 1 New or Replacement Position: New Site:  2400 Skymark Avenue, Mississauga  Department: Quality and Regulatory Reports to: Regulatory Affairs Manager Salary Range: $85,000 - $115,000 annually Hours: 37.5 Hours Per Week Shifts: Days, Monday - Friday Status: Permanent Full-time Closing Date: Open until filledDuties 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.Prepare 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. Prepare country-specific forms for reportable incidents within the required timeline.Lead any required regulatory notices, recalls and field actions.Maintain product UDI listings in country-specific databases.Participate in internal and external audits, providing regulatory input as needed. Coordinate writing and executing corrective action plans for audit nonconformances related to regulatory functions and documents.Assess and document regulatory impact of product design changes in jurisdictions where product is licensed.Oversee post-market surveillance activities for licensed products. Bachelor of Science Degree (or equivalent)Post-Graduate Degree or Certificate in Regulatory Affairs, or equivalent work experience 7+ years’ experience in medical device or biologics regulatory affairsExperience authoring original device submissions in US, Canada, or EUFamiliarity with medical device standards and regulations such as ISO 13485, ISO 14971, EU MDR, US FDA 21CFR, Canada SOR 98/282Excellent written and verbal skillsExcellent organization and file management skillsProficient wi...