The Vice President of QA & Regulatory Affairs provides strategic leadership for quality and regulatory compliance within a Software as a Medical Device (SaMD) environment. They are responsible for motivating high-performance teams, ensuring adherence to global standards, and driving risk-based validation strategies across Agile development cycles.
The Validation Specialist acts as a subject matter expert for an Agile team, translating business workflows and regulatory requirements into testable requirements. They facilitate Agile ceremonies, manage defect identification, and ensure robust verification and validation coverage throughout the software development lifecycle.
The Solutions Architect will design and evolve complex, distributed software systems while partnering with engineering teams to define scalable microservices architecture. They are responsible for implementing event-driven architectures, managing cloud-native deployments on AWS, and ensuring high standards for security and operational excellence.
