Sr. Director of Regulatory Affairs - California, United States - The Mullings Group

Description

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 delivery innovation that will completely redefine transseptal-based mitral and tricuspid 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.