ventilators and anesthesia delivery systems. Experience with FDA design controls and IEC software lifecycle processes. Knowledge...
concepts and standards Demonstrated practice in functional safety standards, including IEC 61508, IEC 62061, ISO 13849...
programs such as SOC2, ISO/IEC 27001, PCI-DSS, FedRAMP or control frameworks such as MITRE ATT&CK, NIST 800-53, OWASP...
, ARP4761, DO-178C, DO-254, IEC 13849, IEC 61508, or equivalent Experience with vehicle body systems, such as HMI, doors...
Standards: Ensure the team adheres to relevant regulatory and quality standards (e.g., ISO 13485, IEC 62304), integrating robust...
, ISO 11607, IEC 62366, IEC 62304;cybersecurity expectations;UDI/EUDAMED and labeling requirements (EU MDR Annex I GSPRs...
-53, ISO 27001, IEC 62443, etc.) implementation and governance Program and Project Management experience;expertise...
-53, ISO 27001, IEC 62443, etc.) implementation and governance Program and Project Management experience;expertise...
), and relevant national cybersecurity mandates. Certification and readiness for critical assurance frameworks such as ISO/IEC 27001... frameworks such as NIST CSF, COBIT, ISO/IEC 27001, SOC 2, PCI DSS, HIPAA, and SOX. Executive-level communication skills with the...
, IEC 62304, and other global regulatory requirements and quality standards) Proven ability to learn and adapt to provide...