Global Regulatory Device Strategy Lead
BioSpace
CSL Behring in King of Prussia, PA seeks a Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist to lead regulatory strategy across plasmapheresis devices, drug-device combos, and standalone devices, coordinating with R&D, Quality, Regulatory Affairs and Global Operations. You will serve as primary liaison to US FDA, oversee submissions (510(k), De Novo, PMAs, CE filings), manage global device registrations, and mentor teams while driving lifecycle management and #J-18808-Ljbffr BioSpace
Vacancy posted 1 day ago
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