Elevate organ transplant solutions with Traferox as a Senior Regulatory Affairs Specialist in Mississauga, Ontario. Drive regulatory submissions and maintain compliance for life-saving products.

Traferox Technologies Inc. is seeking an experienced regulatory affairs specialist with 7+ years in medical device or biologics. You will prepare technical documents for regulatory submissions and ensure compliance with ISO standards and regulations. The role involves maintaining regulatory files across jurisdictions and assessing device-related complaints to adhere to reporting requirements.

Key Responsibilities:
• Prepare regulatory submissions for market-specific requirements
• Maintain updated regulatory files for Canada, US, and EU




• Coordinate responses to regulatory inquiries within deadlines
• Lead recalls and field actions as necessary
• Oversee post-market surveillance for licensed products

Requirements:
• Bachelor of Science or equivalent
• 7+ years in regulatory affairs in medical devices
• Familiarity with ISO 13485 and MDSAP
• Excellent organizational and communication skills
• Proficient with Microsoft Office products

Be a pivotal part of enhancing transplant outcomes through regulatory expertise at Traferox in Mississauga.
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📌 Senior Regulatory Affairs Expert at Traferox (Ontario)
🏢 University Health Network
📍 Ontario