Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery

Johnson & Johnson seeks a Senior Regulatory Affairs Program Lead to develop and execute regulatory strategies for OTTAVA robotic surgical systems. The role involves leading product approvals, preparing FDA submissions, and supporting cross-functional teams through product development and market access.

Responsibilities

• Develop and execute regulatory strategies for new product development and lifecycle management projects
• Prepare, write, and file FDA submissions including Q-submissions, IDEs, De Novos, and 510(k)s
• Serve as regulatory subject matter expert providing feedback on device specifications, testing, risk management, and labeling
• Lead health authority communications and support international regulatory submissions
• Execute sustaining regulatory activities including change assessments and registrations

Requirements

• Bachelor's degree minimum; advanced degree strongly preferred
• 6+ years regulatory affairs experience with medical devices and software-enabled systems
• Proven track record obtaining 510(k)s, IDEs, or De Novo approvals
• Expert knowledge of FDA guidances, regulations, and applicable standards
• Experience with electromechanical devices and FDA software/cybersecurity requirements
• Collaborative communicator able to influence across functions and navigate ambiguity