Base: $79,400.00 to $132,400.00; bonus/equity: 7.5...
Design control and risk management
Compliance with quality and regulatory standards
Cross functional team collaboration
This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, MO or Andover, MA
Job Summary
This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, MO or Andover, MA.
The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.
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
This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, MO or Andover, MA.
Salary
Base: $79,400.00 to $132,400.00; Bonus/Equity: 7.5% of base salary; Benefits: 401(k) with matching, paid leave, medical, dental, vision coverage
Skills & Requirements
Must-have
Design control and risk management
Compliance with quality and regulatory standards
Cross functional team collaboration
Regulatory submission support
Device design and manufacturing investigations
Proficiency in general computer software
Nice-to-have
Knowledge of FDA and ICH guidance
Device risk management expertise
Human Factors Engineering familiarity
Project management methodologies
Statistical analysis of test results
Device assembling manufacturing process
Key Requirements
BS degree with 6 to 8 years relevant experience
MS degree with 4 to 6 years relevant experience
Thorough 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