Description:

Key Responsibilities

- Lead the development, organization, and maintece 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 RD, 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:

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Assistant Manager, Drug Device Development (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad