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 transparent, 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

Education:

- Bachelors Degree (BA/BS) B. Sc. - Required

- Master Degree (MS/MA) M.Sc. - Preferred

Experience:

- 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

📌 Assistant Manager, Product Delivery Development (India)
🏢 Amneal Pharmaceuticals
📍 India