About the Job Lead software testing activities for medical device software ensuring compliance with regulatory standards like IEC 62304 ISO 14971 ISO 13485 and cybersecurity guidelines Collaborate across teams to document verify and validate software support audits and contribute to regulatory submissions Technical Skills Manual software Verification Validation V V Experience with cybersecurity standards and ISMS documentation ISO IEC 27001 Risk management hazard analysis traceability Test planning execution and defect management Regulatory documentation Behavioral Skills Detail-oriented and quality-focused Solid collaboration and cross-functional communication Analytical thinking for risk and defect analysis Proactive in process improvements Comfortable in regulatory and audit environments Review and document test plans protocols and reports in compliance with IEC 62304 ISO 14971 ISO 13485 and cybersecurity guidelines Document manual verification and validation V V of software requirements design and implementation Ensure proper documentation of testing activities defect reports and traceability requirements risks tests results Participate in risk management activities by identifying analyzing and mitigating software-related hazards Prepare Information Security Management Systems and cybersecurity-related documents Work closely with development QA and regulatory teams to ensure compliance with regulatory standards FDA MDR IEC 62304 ISO 14971 ISO IEC 27001 Cybersecurity Guidelines Contribute to test documentation for regulatory submissions e g FDA 510 k CE marking Support audits and regulatory inspections by providing evidence of testing and risk management activities Participate in continuous improvement of the quality system and test processes

📌 Lead - Software Testing (Karnataka)
🏢 Remidio
📍 Karnataka