Principal Toxicologist

3 months ago

Northfield, Minnesota, United States Medline Industries Full time
MINIMUM JOB REQUIREMENTS
COVID-19 Vaccination
Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.
Education
  • Bachelor's degree in Chemistry, Biochemistry, Biology, toxicology, or related science field.
Work Experience
  • 10 years industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility and toxicology.
Knowledge / Skills / Abilities
  • Knowledge of FDA requirements and experience with FDA interactions as part of the 510k approval processes
  • Knowledge of CE technical files
  • Working knowledge of FDA and EU MDR and other global medical device regulations and/or biologics regulations, ISO 10993, and 14971.
PREFERRED JOB REQUIREMENTS
  • Active Diplomate of the American Board of Toxicology (DABT) certification
  • Experience and Knowledge of ISO 18562.
  • Experience in chemical characterization risk assessment
  • Experience and knowledge of pharmaceutical related field.
  • Experience of quality audit by external regulatory bodies (FDA, EU Regulatory body, etc.).
  • Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.
  • Experience communicating with internal and external business partners and cross functional teams with various audiences.
Knowledge / Skills / Abilities
  • Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site.
  • Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills.
  • Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates.
  • Ability to influence and motivate others to drive results in a multi-location and matrixed environment.
  • Ability to manage multiple projects in cross functional teams.
  • Comfortable in a dynamic environment and able to work independently as well as on teams.
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