$68,600.00 - $114,300.00; bonus target of 7.5%; co...
Design control lifecycle
Combination product development
Regulatory standards compliance
The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle
Job Summary
The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.
Ensures that combination product development activities are compliant with quality and regulatory standards – both internal and external.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
Matching Summary
The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.
Salary
$68,600.00 - $114,300.00; Bonus target of 7.5%; Comprehensive benefits package
Skills & Requirements
Must-have
design control lifecycle
combination product development
regulatory standards compliance
risk management activities
design validation support
regulatory submission data
Nice-to-have
human factors engineering
usability engineering
project management methodologies
device assembling manufacturing process
complex data analysis
Key Requirements
BS degree with 3+ years experience OR MS degree with 0+ years experience
Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040, EU Medical Devices Directive, EN 62366, EU Medical Devices Regulation