Cyber Security Assessor

**Tasks**
- The expert is responsible for assessing the safety and performance of medical devices in aspects of cybersecurity to ensure that manufacturers comply with relevant regulations and standards.
- ** Key Responsibilities**:

- Understanding of cybersecurity principles, practices, and frameworks, with a focus on medical devices
- Ensuring the various phases of security lifecycle and the corresponding documentation needs for each phase are carried out
- Assessing security life cycle process to align with best practices
- Understanding of security incident response plans and procedures, including documentation of incident handling and reporting protocols
- Reviewing and assessing technical documentation related to cybersecurity for software-enabled medical devices, including security risk assessments, cybersecurity architecture, threat models, security controls, and vulnerability assessments
- Evaluating cybersecurity risk management processes and documentation, ensuring appropriate identification, assessment, and mitigation of cybersecurity risks

**Qualifications**
- ** Qualifications**:

- Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field
- At least 2 years of experience in cybersecurity related industry and/or software testing (this includes the time for the Bachelor, Master or PHD Thesis)
- Relevant certifications in cybersecurity, for example: ISTQB, CISSP, CISM will be an advantage
- Any knowledge in relevant standards governing medical devices, especially those related to software, such as IEC 62304, IEC 82304-1, will be preferred
- Any knowledge on Standards and regulations such as ISO 13485, and EU Medical Device Regulation (MDR) will be an advantage
- Strong technical writing abilities to provide clear and concise feedback on the technical documentation and communicate assessment findings effectively
- Excellent communication and interpersonal skills to collaborate effectively with manufacturers and other team members. Ability to articulate assessment findings clearly and professionally
- The ability to work independently and as part of a team and under pressure to meet deadlines and maintain confidentiality