Regulatory Affairs Manager - Digital Health Technologies – Diabetes Care (on-site)
Experience with Software Development Lifecycle process, IEC 62304, TIR 45 etc. Proficient with Excel and PowerPoint...
Experience with Software Development Lifecycle process, IEC 62304, TIR 45 etc. Proficient with Excel and PowerPoint...
and apply standards including IEEE, IEC, NESC, and client standards. Experience with power system calculations (AC panel sizing, DC panel...
and apply standards including IEEE, IEC, NESC, and client standards. Experience with power system calculations (AC panel sizing, DC panel...
compliance with the International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) 17025...
understanding of IEC 62443 cybersecurity standards and protocols, along with a proven track record in architecting and overseeing..., including business continuity planning, cybersecurity, and compliance risks. Deep understanding of IEC 62443 cybersecurity...
, writing reports and conducting senior briefings. Familiarity with ICS-specific security frameworks (e.g., NIST SP 800-82, IEC...
of applicable regulations (e.g. ISO13485, IEC 60601-1, IEC 60601-2-37) Experience translating clinical workflows and business...
of applicable regulations (e.g. ISO13485, IEC 60601-1, IEC 60601-2-37) Experience translating clinical workflows and business...
of applicable regulations (e.g. ISO13485, IEC 60601-1, IEC 60601-2-37) Experience translating clinical workflows and business...
of applicable regulations (e.g. ISO13485, IEC 60601-1, IEC 60601-2-37) Experience translating clinical workflows and business...