Description:Biocompatibility Specialist - ToxicologistSupport and consult on projects related to biocompatibility.Certified toxicologist with DABT or ERT certificationAuthor biocompatibility strategy and toxicological risk assessment per ISO 10993 – 1, ISO 10993 – 18, ISO 10993 – 17, ISO 18562 – 1, 2, 3, and 4.Perform biocompatibility gap analysis and write summary report.Review biocompatibility test reports, raw data, and protocols for accuracy, quality, and correctness.Conduct literature search to support biological risk assessment and toxicological risk assessment.Review biocompatibility test reports, raw data, and protocols for accuracy, quality, and correctness.Familiar with medical devices used in breathing gas pathways (e.g., Incubator, Warmer, Anesthesia systems, etc.)Minimum Qualification:Bachelor’s in chemistry, Biology, Pharmacology, Material Science, or related field (or higher)At least 3 – 5 years of experience in medical device or pharmaceutical industry or contract research laboratoryKnowledge of ISO 10993 series of requirements, ISO 18562 series requirements, and FDA guidance for biocompatibilityStrong time management skills to prioritize, organize, track details, and meet deadline for multiple projects.Familiar with medical devices used in breathing gas pathways (e.g., Incubator, Warmer, Anesthesia systems, etc.)Proficient in online search database like, Pubmed, ECHA, IARC, COMTOX, etc.Required skill set: Worker will support the work related to biocompatibility and toxicology of PCS devices.Notes:RemoteVIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description:Biocompatibility Specialist - ToxicologistSupport and consult on projects related to biocompatibility.Certified toxicologist with DABT or ERT certificationAuthor biocompatibility strategy and toxicological risk assessment per ISO 10993 – 1, ISO 10993 – 18, ISO 10993 – 17, ISO 18562 – 1, 2, 3, and 4.Perform biocompatibility gap analysis and write summary report.Review biocompatibility test reports, raw data, and protocols for accuracy, quality, and correctness.Conduct literature search to support biological risk assessment and toxicological risk assessment.Review biocompatibility test reports, raw data, and protocols for accuracy, quality, and correctness.Familiar with medical devices used in breathing gas pathways (e.g., Incubator, Warmer, Anesthesia systems, etc.)Minimum Qualification:Bachelor’s in chemistry, Biology, Pharmacology, Material Science, or related field (or higher)At least 3 – 5 years of experience in medical device or pharmaceutical industry or contract research laboratoryKnowledge of ISO 10993 series of requirements, ISO 18562 series requirements, and FDA guidance for biocompatibilityStrong time management skills to prioritize, organize, track details, and meet deadline for multiple projects.Familiar with medical devices used in breathing gas pathways (e.g., Incubator, Warmer, Anesthesia systems, etc.)Proficient in online search database like, Pubmed, ECHA, IARC, COMTOX, etc.Required skill set: Worker will support the work related to biocompatibility and toxicology of PCS devices.Notes:Remote
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