Consultant for QMS Development & FDA/ISO13485 Compliance for GI Drug-Device Combination Product in North Liberty, IA for Steel Therapeutics

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Consultant for QMS Development & FDA/ISO13485 Compliance for GI Drug-Device Combination Product

Position: Temporary ConsultantLocation: RemoteIndustry: Medical Device/PharmaceuticalsDuration: Project-based, with potential for extension Company Overview:We are an early-stage company developing a pre-clinical drug-device combination product focused on the gastrointestinal (GI) space. As we move toward advancing our product pipeline, we are seeking a highly experienced consultant to help build out our Quality Management System (QMS) in alignment with FDA guidance, ISO 13485, and GMP standards. The consultant will guide our leadership team to ensure compliance while maintaining a lean system, optimized for working with contract manufacturing partners. Key

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