Assistant Manager, Product Delivery Development
About the role
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
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
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:
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