Regulatory Design Controls Lead Transdermal Devices

Aveva Drug Delivery Systems in New York is seeking a Design Controls Specialist to establish and maintain design control processes for transdermal patch products, ensuring compliance with FDA 21 CFR 820, ISO 13485, and applicable guidelines. You will own DHFs, manage ISO 14971 risk analyses, and drive traceability from user needs through verification, validation and design transfer, coordinating with R&D, QA, Regulatory Affairs and Manufacturing.