Sr. Director of Regulatory Affairs
2 weeks ago
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.
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Director/Sr. Director CMC Regulatory Affairs
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Director/Sr. Director CMC Regulatory Affairs
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Regulatory Affairs Coordinator
3 weeks ago
Los Angeles, United States ProKatchers LLC Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill CoordinatorLocation: 91342, Los Angeles, California, United StatesDuration: 06 MonthJob Description:This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. Person...
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Regulatory Affairs Pharma
1 day ago
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