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Hybrid: Remote / Director of Regulatory Affairs / Structural Heart PMA
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- Class III : Structural Heart : PMA
- Delivered through a 12F sheath and over a standard guidewire, the low-profile device features bioresorbable filaments connecting two polyester fabric patches, which contain radiopaque markers.
- The device is fully deployed with the guidewire in place, providing the opportunity to reattach and reposition when necessary.
- Currently seeking a new Global Director of Regulatory Affairs to help spearhead our client's 1st generation PMA submission as well as future supplements and OUS international registries for global commercialization.
- The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval.
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