GEHC - Biocompatibility Specialist - Toxicologist

Job Title Biocompatibility Specialist - Toxicologist
Tentative Start date 04/07/2025
End date 04/02/2026
Work shift 40 hours a week
Work location (Client Business address)- Remote

Required skill set: Worker will support the work related to biocompatibility and toxicology of PCS devices.
Candidate Screen(Interview) Teams
Temp to Perm (Yes/No):

Role: Biocompatibility Specialist - Toxicologist
1) Support and consult on projects related to biocompatibility.
2) Certified toxicologist with DABT or ERT certification
3) Author biocompatibility strategy and toxicological risk assessment per ISO 10993 1, ISO 10993 18, ISO 10993 17, ISO 18562 1, 2, 3, and 4.
4) Perform biocompatibility gap analysis and write summary report.
5) Review biocompatibility test reports, raw data, and protocols for accuracy, quality, and correctness.
6) Conduct literature search to support biological risk assessment and toxicological risk assessment.
7) Review biocompatibility test reports, raw data, and protocols for accuracy, quality, and correctness.
8) Familiar with medical devices used in breathing gas pathways (e.g., Incubator, Warmer, Anesthesia systems, etc.)

Minimum Qualification:
1) Bachelor s in chemistry, Biology, Pharmacology, Material Science, or related field (or higher)
2) At least 3 5 years of experience in medical device or pharmaceutical industry or contract research laboratory
3) Knowledge of ISO 10993 series of requirements, ISO 18562 series requirements, and FDA guidance for biocompatibility
4) Strong time management skills to prioritize, organize, track details, and meet deadline for multiple projects.
5) Familiar with medical devices used in breathing gas pathways (e.g., Incubator, Warmer, Anesthesia systems, etc.)
6) Proficient in online search database like, Pubmed, ECHA, IARC, COMTOX, etc.