Advance your career at Moonrise Medical as the Director of Quality & Regulatory Affairs. Participate in driving quality standards throughout the medical-device lifecycle.

In this leadership position, you'll be responsible for quality assurance from initial product development through commercialization and post-market activities. Collaborating with multi-disciplinary teams, you will ensure rigorous design controls, risk management, and compliance with FDA requirements. This role involves actively contributing to FDA 510(k) submissions and leveraging your regulatory knowledge to enhance quality systems.

Key Responsibilities:
• Guide quality across all phases of product lifecycle
• Direct verification and validation quality activities




• Manage FDA submission strategies and compliance
• Continuously improve Quality Management Systems
• Supervise supplier quality assurance processes

Requirements:
• 10+ years of relevant quality experience in medical devices
• Proven experience with design controls and validation
• Deep understanding of FDA and ISO 13485 standards
• Experience with complex electromechanical devices
• Demonstrated ability to handle cross-functional quality tasks

Lead creative quality practices and regulatory compliance at Moonrise Medical.
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📌 Quality & Regulatory Affairs Director Role (Ontario)
🏢 PulseMedica
📍 Ontario