Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery
. Experience with vision systems, robotics, and connected medical platforms strongly preferred. Experience with IEC 60601 series...
. Experience with vision systems, robotics, and connected medical platforms strongly preferred. Experience with IEC 60601 series...
, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820, or other quality system regulations Excellent written and verbal...
years designing and programming electrical control systems, including SCADA/HMI, IEC 61850, firewalls, cybersecurity...
in regulated development environments such as IEC 62304. Result-oriented, self-motivated and able to participate as both a team...
certifications for IoT/OT domains, such as ETSI EN 303 645 or ISO/IEC 62443. (Bonus) Experience with scripting languages...
About Us: InterSources Inc, is a Small, Woman, and Minority-Owned Business Enterprise, ISO/IEC 27001, SOC 2 Type 2 certified company...
like NIST, ISO 27001, IEC 62443 for industrial cybersecurity, and partner with GRC to maintain policies, standard operating... Understanding of regulatory and safety standards applicable to manufacturing and retail such as OSHA, NIST SP 800-82, ISO/IEC 27019...
product development, including knowledge of federal and international regulations, such as FDA QSR, IEC 60601, ISO: 13485...
compliance efforts related to standards and frameworks such as IEC 62443, ISO 27001, NIST, NERC CIP, and CTPAT What You Bring...
experience, including translation/localization vendors Knowledge / Skills / Abilities Familiarity with ISO/IEC 82079-1...