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Provide strategic regulatory and scientific support on pre-clinical and clinical development plans and work with both Regulatory Affairs - New Products and Regulatory Affairs...
Lead the Design Control process for drug/device combination products and create phase-based Design Control documents (DDP, URS, DRS, DV&V, DTx, DHF, etc.). Determine the...
Monitor and analyze the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which the clients' products are regulated...