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
Base: $79,400.00 - $132,400.00; Bonus/Equity: 7.5% of base salary; Benefits: Comprehensive and generous benefits
Skills & Requirements
Must-have
Design control lifecycle
Combination product development
Quality and regulatory standards
Risk management activities
Human factors engineering assessments
Regulatory submission data
Nice-to-have
Technical leadership for projects
Device assembling manufacturing process
Complex data analysis
Statistical sampling plan
Key Requirements
BS degree with 6-8 years experience OR MS degree with 4-6 years experience
ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040, EU Medical Devices Directive