Director, Cybersecurity Regulatory Affairs

Interface with clients to gather information and review documentation for correctness and compliance with regulatory guidelines to develop submission quality documentation for marketing applications. Conduct risk management and vulnerability analyses on medical devices and support manufacturer’s cybersecurity strategy development, system testing and evaluation, and verification and validation efforts. Review client documentation to identify and inform recommendations for improving policies, processes, and procedures based on new and/or evolving Federal standards, requirements and/or guidelines. Research, review, monitor, and report on industry best practices, latest cybersecurity developments and trends, standards, and guidelines, and apply these to services provided. Stay current on US medical device regulatory requirements.