), 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...
, IEC 62304, and other global regulatory requirements and quality standards) Proven ability to learn and adapt to provide...
: CDPSE (ISACA), CISSP-Privacy, ISO/IEC 27701 Lead Implementer or Auditor, NIST Privacy Framework training, GIAC GCCC & GLEG...
) Experience with one or more of: MDR (Medical Device Regulation) ISO 14971 (risk management) ISO 13485 IEC 62304 SaMD...
) Experience with one or more of: MDR (Medical Device Regulation) ISO 14971 (risk management) ISO 13485 IEC 62304 SaMD...
) Experience with one or more of: MDR (Medical Device Regulation) ISO 14971 (risk management) ISO 13485 IEC 62304 SaMD...
. You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance... IEC 62304 (software lifecycle) and IEC 82304 (health software product safety and effectiveness). Embed regulatory...
architectures. Strong understanding of IEC 61131-3 programming standards, ISO 13849-1 safety standards, and real-time control...
under standards such as ISO 9001, ISO 13485, and ISO/IEC 17025. Market Engagement & Thought Leadership: Develop compelling product..., ISO/IEC 17025) relevant to product development and quality assurance. Demonstrated ability to translate technical...