Assistant Manager, Product Delivery Development
Amneal India · Ahmedabad, Gujarat, India
Pharmaceutical Manufacturing · 5,001-10,000 employees
3 h ago
Senior (5-10 yrs)
Full-time
India
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About the role
The Assistant Manager will lead the development and maintenance of Design History File documentation in compliance with regulatory standards for combination products. They will also collaborate with cross-functional teams to ensure technical intent and traceability across all design and validation activities.
What they look for
Design History File
21 CFR 820.30
Design Controls
Verification And Validation
Risk Management
Regulatory Affairs
Combination Products
Technical Documentation
Traceability
Engineering Design
Quality Assurance
Drug-Device Interfaces
Compliance
Cross-functional Collaboration
Requirements
Candidates must hold at least a Bachelor's degree in a relevant field and possess 8 to 10 years of experience in medical device development. Strong knowledge of 21 CFR 820.30 and experience with design controls in a regulated pharmaceutical environment are required.
Full description
Description:
Key Responsibilities
- 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
