Quality Compliance Manager

VirtualVocations
Seattle, Washington, United States
Full-time
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A company is looking for a Quality & Regulatory Compliance Manager to ensure adherence to regulatory requirements and maintain the integrity of the quality management system.

Key ResponsibilitiesLead continuous improvement of Information Security and Quality Management SystemsOversee core assurance and compliance activities, including internal audits and regulatory body interactionsDevelop and execute regulatory strategies to support product development and market approvalRequired QualificationsBS / MS (or equivalent) in a scientific disciplineAt least four (4) years of experience in regulatory affairs or quality management systems for medical devicesProficiency in ISO 13485 : 2016 and ISO 14971 standardsFamiliarity with IEC 62304 life cycle requirements for software medical devicesExperience with US and international regulatory agency interactions and post-market reporting

2 days ago
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