device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304. Experience implementing various...
with legal, regulatory, and industry standards and requirements (e.g. ISO/IEC 27001/27002, NIST CSF, NIS2, CRA, IEC62443...
, IEC 62304, ISO 14971, cybersecurity). Advanced degree in scientific, engineering, computer science, or regulatory affairs...
, and deployment strategists Ensure compliance with IEC 62304, FDA regulations, and various regulations required in a global... within a regulated industry, operating within a medical quality system, and a solid understanding of IEC 62304, ISO 14971, ISO 13485...
and product safety standards in accordance with the IEC 60601 series. The role involves guiding product development teams through... Responsibilities: Lead EMC and electrical safety compliance programs for medical products, ensuring conformity to: IEC 60601-1...
more at Responsibilities: Design, development, and test software per medical device software development life cycle (IEC-62304) Management...
of manual and automated test plans, test cases, and scripts for embedded software per IEC 62304 Collaborate with embedded...
assessments, compliance audits, and ensure adherence to frameworks like COBIT, ISO/IEC 38500, and ITIL. Policy creation...
standards (e.g., IEC 62304) and maintain relevant SOPs for software development in regulated environments. Talent Development...
device’s IEC 60601-1-2 compliance. Specifications & Drawings: Develop detailed manufacturing specifications & Instructions... or industry/education Required What else we look for (Preferred): Strong working knowledge of IEC 60601-1 and IEC 60601-2...