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
Strong collaboration and cross-functional communication
Analytical thinking for risk and defect analysis
Proactive in process improvements
Comfortable in regulatory and audit environments
Job Description
- 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.
