and associated regulatory requirements (FDA CFRs, ISO, IEC, etc.) Familiarity in robotics, tissue stapling, vessel sealing... (FDA CFRs, ISO, IEC, etc.) Familiarity in robotics, tissue stapling, vessel sealing, and computer controlled small...
, as applicable Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC..., as required Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR)​ as well...
13845, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, HIPAA and/or GDPR, preferred. Minimum certifications...
of Utility Transmission, Substation or Energy Projects. Knowledge of engineering standards including NEC, NESC, NEMA, IEC, IEEE...
credentials are required. Knowledge of common information security management frameworks, such as ISO/IEC 27001, ITIL, COBIT...
Controls, ISO/IEC 27001, NIST Cybersecurity Framework and Federal Information Security Management Act (FISMA) Compliance...
that include motion control interfaces Experience with medical device regulatory standards such as 21 CFR Part 820, IEC 62304...
of Utility Transmission, Substation or Energy Projects. Knowledge of engineering standards including NEC, NESC, NEMA, IEC, IEEE...
development experience and IEC60601-1, IEC62304 and related IEC standard familiarity preferred. Development/Process Tools: MS...
9001:2015 and ISO/IEC 27001:2013 certified small business and appraised at CMMI Level 3 for Services and Development...