QA/RA Manager JB-5610

A medical technology startup developing and commercializing AI-powered Software as a Medical Device (SaMD) is looking for a hands-on QA/RA Manager. This is an individual contributor role, responsible for maintaining quality management systems, ensuring regulatory compliance, and supporting software development processes in a regulated medical environment. Responsibilities: • Manage and maintain the company's Quality Management System (QMS), ensuring compliance with applicable FDA and ISO standards. • Oversee quality processes throughout the Software Development Life Cycle (SDLC), including software verification and validation. • Manage quality documentation, change control processes, CAPA, and risk management activities. • Conduct internal audits and coordinate external regulatory and certification audits. • Support regulatory compliance activities and submissions, including FDA requirements. Requirements: • 3-5 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry, preferably with SaMD. • Proven hands-on experience managing QMS in accordance with ISO 13485, FDA QMSR, and ISO 14971. • Strong knowledge of IEC 62304 and medical software development processes (SDLC). • Experience conducting internal audits and managing external audits. • Hands-on experience using AI tools such as Claude, ChatGPT, and similar platforms in daily workflows - a must.