Browse regulatory and quality roles in cardiac MedTech and cardiovascular medical device companies. This page features opportunities supporting regulatory submissions, quality systems, compliance, and product lifecycle oversight in FDA-regulated environments.
Regulatory and quality professionals play a critical role in ensuring cardiovascular technologies meet global compliance standards, safety requirements, and post-market obligations throughout development and commercialization.
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Regulatory Affairs Specialist, Regulatory Affairs Manager, Director of Regulatory Affairs, Quality Engineer, Quality Systems Manager, Design Assurance Engineer, Compliance Specialist, CAPA Manager, Document Control Manager, and Director of Quality.
Roles in cardiac MedTech often require experience with FDA 510(k) submissions, PMA pathways, CE marking, EU MDR, global regulatory strategy, and post-market surveillance. Quality professionals typically support ISO 13485-certified quality management systems (QMS), design controls, risk management, and audit readiness.
Regulatory and quality teams collaborate closely with engineering, clinical affairs, and manufacturing to ensure product safety, labeling accuracy, technical documentation integrity, and inspection readiness.
Opportunities may span electrophysiology (EP), structural heart, cardiac rhythm management (CRM), interventional cardiology, heart failure technologies, and other cardiovascular device platforms.
Professionals in these roles help organizations navigate complex global regulatory landscapes while maintaining product quality and operational compliance across international markets.