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 continuouslyRequirements:
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 effortsLead transformative quality initiatives and regulatory compliance at Moonrise Medical.#J-18808-Ljbffr

📌 Director Of Quality At Moonrise Medical Hamilton (Canada)
🏢 PulseMedica
📍 Canada