Manager Quality Assurance & Reg Affairs | AirStrip

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager Quality Assurance & Regulatory Affairs | AirStrip based in the United States.

In this role, you will lead Quality Assurance and Regulatory Affairs activities within a medical technology environment, ensuring the highest standards of product quality, safety, and regulatory compliance. You will oversee the continuous improvement of the Quality Management System (QMS) while supporting the development and enhancement of innovative Software as a Medical Device (SaMD) solutions. Working cross-functionally with product development, clinical, and operational teams, you will contribute to regulatory strategy, risk management, and product lifecycle oversight. You will also play a key role in audit readiness, corrective action initiatives, and international market authorizations. This position offers the opportunity to influence quality processes, strengthen regulatory frameworks, and mentor team members in a dynamic, innovation-driven healthcare technology environment.