Senior Regulatory Affairs Program Lead (Software/OTTAVA)
Core
Lead regulatory planning and execution for US and international approval of advanced surgical robotics and software-enabled electromechanical medical devices.
Role type
Senior Regulatory Affairs Program Lead
Builds
Regulatory strategies, submissions (510(k), De Novo, IDE), and lifecycle management for surgical robotics portfolio
Domain
Medical Devices / Surgical Robotics / Software
Deliverable
client delivery
Required skills
Regulatory strategy, FDA submissions, lifecycle management, risk management, health authority interactions, change assessments, international regulatory support
Preferred skills
Health authority meeting preparation, vision systems/robotics background, IEC 60601/ISO 10993 standards, FDA software/cybersecurity knowledge
Responsibilities
Develop and execute regulatory strategies for NPD and LCM; Act as strategic regulatory lead throughout product lifecycle; Review product specs, testing plans, and risk docs; Prepare and submit FDA documentation (Q-Subs, IDEs, De Novo, 510(k)); Lead FDA meetings; Execute sustaining activities (change assessments, renewals); Support international submissions; Ensure compliance during audits