Join Moonrise Medical as a leader in Quality & Regulatory Affairs. Oversee quality management from product development to market entry for innovative medical devices.

This pivotal role demands an experienced quality leader who will shape regulatory strategies and direct comprehensive quality assurance throughout the product lifecycle. You will coordinate with engineering and clinical teams, manage FDA submissions, and implement rigorous quality systems. Your focus will extend to enhancing supplier quality and ensuring compliance with medical-device standards.

Key Responsibilities:



• Drive quality efforts throughout medical-device development • Manage verification and validation procedures • Own and enhance the Quality Management System • Lead FDA 510(k) submission processes • Ensure supplier compliance and quality controls

Requirements: • Minimum 10 years in medical device quality assurance • Extensive hands-on experience in risk management • Robust knowledge of FDA regulations and ISO 13485 • Familiarity with medical-device software requirements • Ability to lead cross-functional initiatives while being hands-on

Ensure the success of revolutionary medical technologies at Moonrise Medical. #J-18808-Ljbffr

📌 Medical Device Quality Leader Moonrise (Winnipeg)
🏢 PulseMedica
📍 Winnipeg