Join Moonrise Medical as a leader in Quality & Regulatory Affairs. Oversee quality management from product development to market entry for creative 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 developmentManage verification and validation proceduresOwn and enhance the Quality Management SystemLead FDA 510(k) submission processesEnsure supplier compliance and quality controlsRequirements:Minimum 10 years in medical device quality assuranceExtensive hands-on experience in risk managementStrong knowledge of FDA regulations and ISO 13485Familiarity with medical-device software requirementsAbility to lead cross-functional initiatives while being hands-onEnsure the success of revolutionary medical technologies at Moonrise Medical.#J-18808-Ljbffr

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