Vice President of Quality Assurance

Job Summary

Leading the global quality and regulatory strategy for a growing Software-as-a-Medical-Device portfolio, the full-time remote or hybrid Vice President of Quality Assurance will manage regulatory engagement, oversee quality systems, and ensure compliance while building strong relationships with regulatory agencies and stakeholders.

Key responsibilities

• Own and evolve the global regulatory strategy aligned with business goals and product roadmap
• Lead the development and continuous improvement of the Quality Management System (QMS) to ensure audit readiness
• Coach and develop a high-performing QA/RA organization while collaborating with cross-functional teams to embed quality requirements into operations

Required qualifications

• Bachelor's degree in a scientific, engineering, clinical, or related discipline (advanced degree preferred)
• 10+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs within medical devices and/or SaMD
• Demonstrated experience working directly with FDA and global regulatory agencies
• Proven track record of leading successful regulatory inspections and audits
• Deep working knowledge of quality management systems and regulatory compliance frameworks