Sr. Director of Regulatory Affairs
Medical Robotics : Cardiovascular
1st Generation Start Series B Start-up
IDE : PMA Submissions
Hybrid : Onsite : Bay Area
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 over $30M+ in recent funding 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 director of regulatory affairs to lead and execute 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.
Hybrid : Remote / Director of Regulatory Affairs / Structural Heart PMA
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