Exciting leadership chance at Moonrise Medical as Director of Quality & Regulatory Affairs. Drive quality and regulatory compliance across the entire product lifecycle for medical devices.

In this high-impact role, you will lead diverse quality functions from product development through to commercialization. Your expertise will guide cross-functional teams to ensure thorough design controls, risk management, and regulatory strategy. You'll actively participate in FDA 510(k) submissions while enhancing the Quality Management System and managing supplier quality activities.

Key Responsibilities:



• Lead quality throughout the medical-device lifecycle • Oversee design controls and Design History Files • Direct risk management and verification validation activities • Manage FDA 510(k) submissions and regulatory activities • Improve the Quality Management System continuously

Requirements: • 10+ years of medical-device quality experience • Hands-on expertise in design controls and risk management • Knowledge of FDA requirements and ISO 13485 • Experience with electromechanical medical devices • Proven ability to lead cross-functional quality efforts

Lead transformative quality initiatives and regulatory compliance at Moonrise Medical. #J-18808-Ljbffr

📌 Director of Quality at Moonrise Medical (Winnipeg)
🏢 PulseMedica
📍 Winnipeg