Cybersecurity Regulatory Affairs Director

Job Summary

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