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...
from an accredited university or college Have a minimum of 8 years of regulatory and product certification experience (ATEX, UL/CSA, IEC...
) are preferred. OT Security focused certifications preferred (GICSP, GRID, ISA/IEC 62443 Series etc) Minimum of 7 years... of experience in cybersecurity. Deep understanding of OT Security standards such as ISA/IEC 62443, NIST 800-82, etc. Proficiency...
and ISO 13485. IEC 60601 and IEC 62304 experience a plus. Experience in medical device and/or regulated industry...
and ISO 13485. IEC 60601 and IEC 62304 experience a plus. Experience in medical device and/or regulated industry...
and IEC 62304 to support work with little or no supervision Applies comprehensive knowledge of software quality concepts...
and testing required to obtain safety, EMC/wireless and similar certifications. Experience with the relevant UL, CSA, FCC, IEC... with the relevant UL, CSA, FCC, IEC and EN directives and standards is required. Broader experience with RoHS, WEEE, REACH...
requirements conducting gap assessments on new standards such as IEC/EN 62304, ISO/EN 14971, Quality Management Systems... in accordance with ISO 13485, FDA 21 CFR 820 and EU MDR 2017/745, IEC/EN/CSA/AAMI 60601-1/80601-1. Experience supporting US FDA 510...
-related issues as necessary. Keep current of MDR regulations and best practices for medical device human factors (e.g. IEC...