Senior Manager, Product Delivery Development

Key Responsibilities

• Lead the Device Development department in Amneal India R&D settings

• Manage direct reportee(s)

• Lead the development, organization, and maintenance of Design History File (DHF) documentation in compliance with 21 CFR 820.30, combination product requirements, and internal procedures

• Author and technically own key design control deliverables, including design inputs, system requirements, design outputs and specifications, verification and validation protocols, reports, and design review documentation

• Ensure robust traceability between user needs, drug–device interfaces, risk controls, design outputs, and verification and validation activities

• Collaborate with cross functional teams such as R&D, Analytical, Quality, manufacturing, CMC and Regulatory Affairs to ensure consistent technical intent across development artifacts

• Capture design rationale and engineering decisions in a clear, defensible manner suitable for regulatory review

• Support integration of device development activities within broader drug development timelines and program milestones

• Assess and manage documentation and technical impacts of design changes throughout development and lifecycle management

• Participate as a technical contributor in risk management activities, design reviews, and cross-functional working sessions

• Support inspection and audit readiness by ensuring DHF completeness, clarity, and consistency across combination product documentation