Digital Health Regulatory Affairs Manager

Johnson & Johnson seeks a Digital Health Regulatory Affairs Manager to lead FDA strategy for cardiovascular medical devices, with emphasis on software, cybersecurity, and AI/ML compliance. The remote role involves managing submissions for Class II & III devices, serving as liaison across global regulatory teams, and supporting product development in heart recovery technologies.

Responsibilities

• Develop and execute FDA clearance and approval strategies for Class II & III cardiovascular devices and product improvements
• Lead compilation of submission materials, prepare FDA filings, and respond to agency pre-submission inquiries
• Provide regulatory guidance on cybersecurity, software, systems engineering, and digital health policy across product portfolio
• Support cross-functional teams on new product development with focus on software, cybersecurity, and hardware regulatory aspects
• Monitor and interpret evolving global digital health regulations to inform submission strategies and maintain compliance

Requirements

• 6+ years regulatory affairs experience with bachelor's degree, or 5+ years with advanced degree
• Bachelor's degree in computer science, engineering, or science required
• Medical device industry experience with successful FDA submissions in cybersecurity, SiMD, and SaMD
• Proven ability to independently communicate with FDA reviewers and lead Q-sub meetings
• Software device development experience including IEC 62304, cybersecurity 524B, and ISO 13485 compliance
• Strong regulatory writing, problem-solving, and project management skills