Aufgaben
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
Qualifikationen
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