Director, Cybersecurity Regulatory Affairs - Remote

Overview

The Director, Cybersecurity Regulatory Affairs will provide consulting advisory services to MCRA clientele, focusing on FDA requirements for cybersecurity in medical devices.

In Short

• Interface with clients to ensure compliance with regulatory guidelines.
• Conduct risk management and vulnerability analyses on medical devices.
• Review and improve client documentation based on federal standards.
• Research and report on cybersecurity developments and best practices.
• Stay current on US medical device regulatory requirements.

Requirements

• Bachelor’s degree in engineering, science, or related field; advanced degree preferred.
• 6-8 years of experience in Regulatory Affairs for medical devices.
• 5+ years of experience in information/cyber security.
• Consulting or client-facing experience preferred.
• Understanding of medical device development and cybersecurity strategies.
• US regulatory experience with FDA regulations.
• Familiarity with threat analysis and risk assessments.
• Knowledge of cybersecurity concepts and principles.
• Strong communication skills for client interactions.
• Ability to manage tasks independently and adapt to changes.

Benefits

• Competitive salary and benefits package.
• Opportunity to work with a leading medical device advisory firm.
• Engagement with a diverse global clientele.
• Professional development and growth opportunities.
• Collaborative work environment with industry experts.