Regulatory affairs Jobs in Phoenix, AZ

A company is looking for a Director, Cybersecurity Regulatory Affairs. Key Responsibilities Interface with clients to gather information and ensure compliance with regulatory guidelines for submission documentation Conduct risk management and vulnerability analyses on medical devices and support cybersecurity strategy development Research and report on industry best practices and evolving cybersecurity standards to enhance client services Qualifications Bachelor's degree in engineering, science, information systems, or a related field; advanced degree preferred 6-8 years of experience in Regulatory Affairs related to medical devices, including writing / reviewing US regulatory submissions 5+ years of experience in information / cyber security Understanding of medical device development concepts and technical background in software and cybersecurity strategies Fluency with FDA regulations and experience with pre- and post-market management of cybersecurity guidance documents preferred