Senior Manager, Regulatory Affairs Device (Hybrid)
Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors...
Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors...
. Demonstrates familiarity with EMC testing standards and methods (e.g., MIL-STD-461, IEC 61000 series), common test equipment...
, with particular attention to IEC 62304, IEC 60601-1, and other relevant FDA requirements. Collaborate closely with cross-functional...
in Electrical Engineering Experience with IEC60601-1 and other regulatory standards (UL/ETL/IEC, ISO, FDA) Knowledge of EMC...
through site visits. Participating in industry forums (IEEE, SEE, IEC, etc.), organizations, and benchmarking activities...
teams to create, test, and debug PLC code using CodeSys and other IEC-3 standard programming languages. Your role..., supporting other IEC-3 standard programming languages. Integrate EtherCAT networked servo drives for multi-axis systems using...
, Woman, and Minority-Owned Business Enterprise, ISO/IEC 27001, SOC 2 Type 2 certified company with massive 18+years...
(IEEE, IEC, UL, NEMA) and identify any risks or deviations. Assist in mentoring junior engineers;provide technical... customer needs. Working knowledge of ANSI, IEEE, UL, NEMA standards;awareness of IEC standards and their application...
creation, documentation, and process implementation. You will apply your understanding of UL/CSA, IEC/EN and other global...
programming experience, especially Siemens-based. Knowledge of international electrical/safety standards such as UL, ISO, and IEC...