of regulatory frameworks (NIST, ISA/IEC 62443, NERC CIP, etc.) relevant to OT security Proven excellent analytical, problem-solving...
of regulatory frameworks (NIST, ISA/IEC 62443, NERC CIP, etc.) relevant to OT security Proven excellent analytical, problem-solving...
standards (e.g. NIST, ISO/IEC 27001, MITRE security framework, etc.) is highly desired. Key Responsibilities: In general..., including NIST, IEC 60601-4-5, and IEC 81001-5-1. Conduct regular assessments and collaborate with development teams to enforce...
Familiarity with FDA 510(k) ultrasound regulatory guidance, IEC 60601 acoustic safety, and MI/TI reporting Experience interfacing...
& Inspection Readiness Ensure conformance to FDA QSR / 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and other global...
/electro-mechanical systems, electrical V&V (IEC 60601, EMC/EMI), automated test equipment (LabVIEW/TestStand), electrical...
with regulatory standards (IEC 60601, ISO 13485, FDA requirements). Knowledge of hardware/software interoperability and scalable...
regulations and standards, including ISO 13485, ISO 14971, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP...
regulations and standards, including ISO 13485, ISO 14971, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP...
of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and IEC 62304. Expertise... (IEC 62366) and its application to enhance product safety and effectiveness. Awareness of software security principles...