Assistant Manager Product Delivery Development

Description

JOB 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
  
  

• Bachelors Degree (BA/BS) B. Sc. - Required
• Master Degree (MS/MA) M.Sc. - Preferred
  
  

• 8 years or more in 8 - 10 Years