Enhance your regulatory expertise as a Regulatory Affairs Specialist at Traferox Technologies. This permanent full time role focuses on compliance for life-saving medical devices in global markets.In this role, you will support regulatory compliance for medical devices across Canada, the U.S., and Europe. You will prepare submissions, maintain facility licenses, and ensure adherence to standards like ISO 13485 and FDA regulations. This position is key to ensuring transplanted organ products remain compliant throughout their lifecycle.Key Responsibilities:Prepare technical documents for regulatory submissionsMaintain regulatory files for multiple marketsManage product licenses and registrationsAssist with regulatory authority inquiries and updatesParticipate in post-market surveillance and audit supportRequirements:Bachelor of Science or equivalent required3+ years in medical device regulatory affairsFamiliarity with ISO 13485 and FDA regulationsExcellent written and verbal communication skillsStrong organization and file management abilitiesApply your regulatory skills to drive compliance and improve patient outcomes at Traferox Technologies.

📌 Regulatory Affairs Specialist At Traferox (Mississauga)
🏢 University Health Network
📍 Mississauga