Vice President of Quality Assurance

A company is looking for a Vice President of Quality Assurance and Regulatory Affairs. Key ResponsibilitiesEstablish, maintain, audit, and continuously improve the Quality Management System (QMS) and compliance programs Lead the QA/RA Department functions, budget, and development while aligning activities with the company's business strategy Oversee regulatory strategy, quality operations, and ensure product safety and compliance with applicable regulationsRequired QualificationsExtensive experience in Quality Assurance and Regulatory Affairs, particularly in Software-as-a-Medical-Device (SaMD) Knowledge of FDA Quality Management System Regulation, ISO 13485, MDSAP, and EU MDR standards Proven leadership skills in managing QA/RA departments and cross-functional teams Experience with regulatory submissions and post-market surveillance activities Ability to act as a Subject Matter Expert during audits and regulatory interactions