R&D Integration Project Leader II

Responsibilities

• Lead R&D project management for drug products, medical devices, and regulated healthcare products
• Own R&D program schedule creation, tracking, and execution
• Integrate inputs from subject matter experts into project proposals, schedules, and technical risk assessments
• Manage project execution, including tracking status, risks, budget, and external spend
• Ensure adherence to FDA, ISO, and IEC design control procedures and standards
• Prepare project reports and deliver presentations to R&D leadership
• Lead scheduled R&D meetings, manage agendas, and follow up on action items
• Establish project communication channels and archives
• Facilitate R&D project design reviews and change control meetings
• Manage purchase orders and approve invoices for external vendors
• Identify and evaluate interactions, dependencies, and synergy opportunities across parallel projects

Requirements

• Experience in R&D project management for regulated healthcare products
• Knowledge of FDA, ISO, and IEC design control procedures
• Ability to manage project schedules, budgets, and technical risk assessments
• Strong leadership and cross-functional collaboration skills

About the Company

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care.