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% bonus target; Benefits: 401(k) plan with Pfizer Matching Contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, health benefits
Skills & Requirements
Must-have
design control lifecycle
combination product development
ISO 13485
ISO 14971
21 CFR 820
ISO 11040
EU Medical Devices Directive
Nice-to-have
human factors engineering
usability engineering
project management methodologies
device assembling manufacturing process
statistical analysis of test results
Key Requirements
BS degree with 6-8 years experience OR MS degree with 4-6 years experience
Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040, EU Medical Devices Directive
Working knowledge of EN 62366 and EU Medical Devices Regulation