Senior Regulatory Affairs Leader
Medical Robotics : Structural Heart
Class III Original PMA Submissions
Hybrid : Bay Area : Full Time Direct Hire
Our office has partnered with a transformational new Bay Area medtech start-up utilizing advanced robotics to combat structural heart disease.
Our client is developing a revolutionary new robotic-assisted transcatheter valve replacement platform empowering physicians with precision control and stability improving patient outcomes on traditional heart valve procedures.
With a substantial recent financing round alongside a world-class team of cardiovascular and surgical robotic SMEs, Capstan has an opportunity to deliver innovation that will completely redefine transseptal-based heart valve procedures.
Currently seeking a new Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations
This is a critical component toward Capstan Medical’s future operations leading the organization through its upcoming IDE award, and fostering a clear and collaborative communication line with the FDA to ensure a successful PMA submission and approval.
Ideally seeking a background in cardiovascular solutions however open to alternative medical implantables, robotics, and/or class III medical electronics with prior successful PMA approval.
