Principal Toxicologist

Principal Toxicologist, Toxicology & Biocompatibility (R&D - MedTech)

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):

• Vacation 120 hrs/yr


• Sick 40 hrs/yr (CO 48; WA 56)


• Holiday pay 13 days/yr


• Work/Personal/Family time up to 40 hrs/yr


• Parental leave 480 hrs


• Bereavement 240 hrs immediate/40 hrs extended


• Caregiver leave 80 hrs


• Volunteer 32 hrs


• Military Spouse time-off 80 hrs