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

QUALIFICATIONS

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, Drug Device Development (Ahmedabad)
🏢 Amneal
📍 Ahmedabad