Principal Toxicologist Job Cincinnati area,Ohio USA,Healthcare

Principal Toxicologist, Toxicology & Biocompatibility (R&D - Med Tech)
Responsibilities

Serve as SME/technical lead for toxicology and biocompatibility for medical devices (including biosorbable/implantable materials).
Evaluate biological safety of device products/materials per international regulations/standards, GLP, and internal procedures.
Plan, execute, coordinate, and interpret in vitro/in vivo biocompatibility and toxicology studies.
Apply ISO 10993 and regulatory requirements; solve biocompatibility problems.
Coordinate biocompatibility test strategies; review, interpret, and summarize data; support risk assessment documentation.
Provide technical guidance to cross-functional internal teams and external partners across the product lifecycle.
Support audits and regulatory/notified body requests (e.g., TUV, BSI) and submissions/reviews.
Identify/evaluate risks and drive resolution; participate in continuous improvement.
Ensure compliance with health/safety/environment practices and relevant regulations.

Qualifications/Requirements

MS or Ph.D. in Toxicology (or related field).
6+ years in medical devices; 8–10 years in toxicology/biocompatibility assessments (medical device/pharma/consumer products); medical device experience strongly preferred.
Experience in regulated medical device safety environment (submissions/audits; worldwide registration preferred).
Experience with absorbable biomaterials for implantable devices (degradation, toxicokinetics) required.
Knowledge of biocompatibility/toxicology assessments and ISO 13485/ISO 10993/ISO 14971 and design control systems.
Laboratory animal care/use strongly preferred; manufacturing-process understanding strongly preferred.

Required/Preferred Skills

Cross-functional collaboration, conflict resolution, technical leadership/mentorship.
Strong written/verbal communication; proactive analytical problem-solving; tenacity.
Travel up to 10%.

Benefits (time off):

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