oracle
Assistant Manager, Drug Device Development
Amneal
Gujarat, IND
Onsite
Discovered Today
Free
Job Fit Check
Base Career helps you apply smarter for this job.
?%
Ready to ScanFull Job Posting
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
About Amneal
Pharmaceutical Manufacturing
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Amneal
Senior Officer, IT User Support
, IND
Senior
Description: The role is responsible for providing day-to-day technical support to employees for a range of hardware and software systems. The role focuses on diagnosing user-reported issues through discussions, performi
Discovered TodayView →
Senior Facilities Engineer, Sterile
Brookhaven, USA
Senior
Description: The Senior Facilities Engineer will lead construction, utilities, and equipment installation for the sterile facility, ensuring all systems meet design and operational requirements. This position will be res
Discovered TodayView →
Senior Officer, IT User Support
Hyderabad, IND
Senior
The role is responsible for providing day-to-day technical support to employees for a range of hardware and software systems. The role focuses on diagnosing user-reported issues through discussions, performing troublesho
Discovered TodayView →
HVAC Mechanic - Tuesday - Saturday
Brookhaven, USA
Mid
Description: The HVAC Mechanic is responsible for maintaining all HVAC systems which includes Air Handling Units, Humidification/dehumidification systems, Chillers, Fan coil Units, Water source heat pumps, Refrigeration
Discovered TodayView →
Assistant Manager, Regulatory Affairs
, IND
Manager
Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practices throughout product development
Discovered TodayView →
Applied AI Scientist – R&D and Regulatory
Bridgewater, USA
Mid
The Applied AI Scientist — R&D and Regulatory builds and deploys AI systems that accelerate product development and regulatory submissions. The role applies natural language processing, document intelligence, and generat
Discovered TodayView →
Sales Representative (Buffalo, NY - ENDO)
Buffalo, USA
Mid
Description: The Sales Representative plays a crucial role in implementing marketing & sales strategies to promote our products effectively with our ENDO Sales Team. The incumbent will deliver balanced and informative sa
Discovered TodayView →
Senior Process Engineer, Sterile
Brookhaven, USA
Senior
Description: The Senior Process Engineer in sterile manufacturing will ensure the compliant, efficient, and safe transfer of new products, implementing manufacturing processes from concept to launch, including scaling up
Discovered TodayView →
Senior Officer, IT User Support
, IND
Discovered Today
Senior Facilities Engineer, Sterile
Brookhaven, USA
Discovered Today
Senior Officer, IT User Support
Hyderabad, IND
Discovered Today
HVAC Mechanic - Tuesday - Saturday
Brookhaven, USA
Discovered Today
Assistant Manager, Regulatory Affairs
, IND
Discovered Today
Applied AI Scientist – R&D and Regulatory
Bridgewater, USA
Discovered Today
Sales Representative (Buffalo, NY - ENDO)
Buffalo, USA
Discovered Today
Senior Process Engineer, Sterile
Brookhaven, USA
Discovered Today