Lake Forest, CA18 days ago
Strong knowledge of 21 CFR Part 11, 21 CFR Part 820 (QSR), ISO 13485, IEC 62304, ISO 14971, EU MDR, and Data Integrity (ALCOA) principles, IEC 82304-1, IEC 81001-5-1, IEC 62366 usability engineering, US FDA cybersecurity expectations, and secure development practices. This role partners closely with Quality Assurance, Regulatory Affairs, Research and Development, Manufacturing, Cyber and Data Security, Infrastructure, and business stakeholders to ensure compliant, scalable, and modern validation governance across regulated enterprise, manufacturing, and Software as a Medical Device (SaMD) platforms.