The Sr. Regulatory Affairs Program Lead will help OTTAVA reach US and international regulatory (NPD) approval goals, leading regulatory strategy development and execution for the robotic systems portfolio.
Locations (2)
Cincinnati, Ohio, United States
Santa Clara, California, United States
Compensation
The anticipated base pay range for this position is : $112,000.00 - $180,550.00
For Bay Area: $129,000.00 - $208,150.00
Responsibilities
Prepare and execute regulatory strategies for NPD and LCM projects
Serve as strategic regulatory lead across product development, submission, approval, and LCM activities
Conduct reviews and provide expert regulatory feedback for specifications, device testing, risk management, labeling and other relevant documentation
Prepare and submit regulatory information required to obtain timely US market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s)