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: $68,600.00 - $114,300.00; Bonus/Equity: 7.5% bonus target; Benefits: 401(k) plan with Pfizer Matching Contributions, additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, health benefits (medical, prescription drug, dental, vision)
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
current US and global Regulations
FDA and ICH guidance
statistical sampling plan
project management methodologies
technical leadership for projects
device assembling manufacturing process
Key Requirements
BS degree with 3+ years experience
MS degree with 0+ years experience
Working knowledge of ISO 9001, ISO 13485, ISO 14971
Working knowledge of 21 CFR 820, ISO 11040
Working knowledge of EU Medical Devices Directive
Working knowledge of EN 62366
Working knowledge of EU Medical Devices Regulation