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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...
This role is responsible for managing and further developing personnel in the QC Laboratory. This includes managing teams in QC Operations (Microbiology & Chemistry) and AS&T...
The position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables...
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...
The Director Assay Development leads an international and multidisciplinary team of scientists and lab technicians who have their main focus on developing a completely new...
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...