POSTED: July 16, 2019
BUSINESS: Cook Biotech, Inc.
START DATE: Immediate Availability


  • Conduct toxicological and biocompatibility assessment of new product design, design changes, manufacturing process and post-production life-cycle activities.
  • Act as the subject matter expert (SME) for the design and execution of toxicological and biocompatibility testing. Advise Engineering on data requirements and biocompatibility and toxicological risk control strategies.
  • Author Toxicological and Biological risk assessments for regulatory compliance.
  • Provide advise on testing strategy and test design.
  • Work with Regulatory Affairs to answer feedback from regulatory agencies on issue relating to biological safety.
  • Prepare and present technical presentations to key stake holders.
  • Maintain and evolve quality system documentation and procedures relevant to toxicological and biological risk assessment.
  • Train staff on new procedures/documents.
  • Maintain strong relationship with external test labs.
  • Remain current and apply the understanding of ISO 10993, ISO 14971 and regulatory agency guidance documents (e.g. FDA, PMDA etc.) and CBI quality system requirements.


  • Ability to manage multiple projects in cross functional teams.
  • Strong written and verbal communication skills of technical subject matter.
  • Understanding of analytical chemistry methods. Knowledge of animal testing is a plus.
  • Laboratory experience in analytical chemistry and/or in vitro or in vivo


  • PhD degree in Toxicology OR relevant experience combined with internationally recognized certification in toxicology.
  • Experience from medical device or pharmaceutical industry is a plus.
  • Knowledge of ISO 10993 and interpretation in domestic and international regulatory settings is a plus.
  • Must have good knowledge to use available toxicological software or database to analyze and interpret test results.


Interested candidates please send cover letter and resume to


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