Regulatory Affairs Specialist at Traferox

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 submissions

• Maintain regulatory files for multiple markets

• Manage product licenses and registrations

• Assist with regulatory authority inquiries and updates

• Participate in post-market surveillance and audit support

Requirements:

• Bachelor of Science or equivalent required

• 3+ years in medical device regulatory affairs

• Familiarity with ISO 13485 and FDA regulations

• Excellent written and verbal communication skills

• Strong organization and file management abilities

Apply your regulatory skills to drive compliance and improve patient outcomes at Traferox Technologies.