Senior Manager, Product Delivery Development
Amneal India · India
Pharmaceutical Manufacturing · 5,001-10,000 employees
3 h ago
Principal (10+ yrs)
Full-time
India
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About the role
Lead the Device Development department and manage the organization and maintenance of Design History File documentation in compliance with regulatory standards. Collaborate with cross-functional teams to ensure technical intent is captured across drug-device interfaces and development artifacts.
What they look for
Device Development
Design History File
21 CFR 820.30
Design Controls
Risk Management
Regulatory Compliance
Combination Products
Verification And Validation
Technical Documentation
Cross-functional Leadership
Engineering Design
Quality Assurance
Project Management
Regulatory Affairs
Lifecycle Management
Requirements
Requires extensive experience in medical device development within a regulated pharmaceutical environment. Candidates must possess strong technical expertise in design controls, risk management, and regulatory documentation.
Full description
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
