Job Details

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 programsLead the QA/RA Department functions, budget, and development while aligning activities with the company's business strategyOversee 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 standardsProven leadership skills in managing QA/RA departments and cross-functional teamsExperience with regulatory submissions and post-market surveillance activitiesAbility to act as a Subject Matter Expert during audits and regulatory interactions