Preclinical Scientist

Critical Innovations LLC

US
**
Preclinical study coordination
Animal model selection and design
Cro vendor management
** Critical Innovations LLC is seeking a Preclinical Scientist to coordinate and scientifically plan preclinical studies, primarily involving live-animal testing. The ideal candidate should possess a graduate-level education and experience in translational research, particularly in medical devices or related fields, and be able to communicate complex scientific findings effectively. **

Job Summary

  • The role involves coordinating and scientifically planning live-animal preclinical studies to ensure product safety, efficacy, and performance.
  • Candidates must possess the ability to translate product-development questions into defensible study designs while managing external Contract Research Organizations.
  • This position requires maintaining Design History Files in compliance with ISO 13485 and supporting FDA submissions with rigorous data analysis.

Matching Summary

Match Score: 75

** Critical Innovations LLC is seeking a Preclinical Scientist to coordinate and scientifically plan preclinical studies, primarily involving live-animal testing. The ideal candidate should possess a graduate-level education and experience in translational research, particularly in medical devices or related fields, and be able to communicate complex scientific findings effectively. **

Skills & Requirements

Must-have

  • Preclinical study coordination
  • Animal model selection and design
  • CRO vendor management
  • Regulatory submission support
  • Data analysis and interpretation
  • GLP and ISO 13485 compliance

Nice-to-have

  • Experience with trauma or hemostasis studies
  • Strong cross-functional communication skills
  • Grant proposal writing experience
  • Patent disclosure preparation
  • Critical care physiology knowledge

Key Requirements

  • Graduate-level training in relevant scientific field
  • Experience designing preclinical animal studies
  • Knowledge of FDA Quality System Regulation 21 CFR Part 820
  • Understanding of Good Laboratory Practices (GLP)
  • Familiarity with ISO 10993 Biocompatibility standards

Work Rights

Not specified

Tailored Resume

Cover Letter