Experience with designing for compliance to IEC 60601-1. RF Design/Testing experience. Medical device or biomedical device...
, ISO 17799, ISO/IEC 27002, ITIL etc.) 2+ years of experience conducting information security internal controls...
Identification and interpretation of recognized standards for medical device performance (e.g. EN 45502, IEC 60601, etc.) Ensure... design meets and exceeds product specifications, regulatory requirements, and international safety standards such as IEC...
plants Knowledge of pertinent regulatory, electrical, and safety standards from NRC, ANSI B11, NFPA, OSHA, IEC, ISO, WAC...
of US and international medical device regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971..., AAMI TIR57, IEC 60601 series, IEC 62366. Solid understanding of developmental best practices for medical device software...
Controls (CSC), and NIST, including 800-63 and relevant ISSO/IEC standards. Advanced scripting skills (e.g., PowerShell...
. Headquartered in Sterling, Virginia, NRI is an established CMMI Maturity Level 3 and ISO 9001: 2015, ISO/IEC 20000-1:2011, ISO/IEC...
, required Preferred Requirements & Qualifications: Supervisory experience Successful completion of auditor training, ISO/IEC 17025, ISO...
environment Additional Preferred Skills: * Familiarity with IEC 61131-3 standard Familiarity with Rockwell, Siemens... platforms of Legacy Embedded Systems Experience with ISO/IEC/IEEE Systems and Software Standards Additional Information...
and commercial activities (e.g., ISO/IEC, FCC, import/export). Manage and execute global copyright and trademark strategy. Work... as a practicing attorney, with a focus on commercial transactions, sales & marketing, and regulatory compliance (e.g., ISO/IEC, FCC...