Senior Toxicologist – Biocompatibility & E&L Lead

Acist Medical Systems Inc.; Eden Prairie (MN); On-site; USD 160,000 - 173,000; Full time

Benefits offered by this job

PTO & Holidays

401(k) retirement plan

Medical, dental, vision insurance

Job summary

Bracco Medical Technologies seeks a Senior Scientist, Toxicologist to lead biocompatibility testing and risk assessments for Bracco medical devices. You will drive BEPs and BERs, ensure ISO 10993 compliance, and guide cross-functional teams on safety and regulatory submissions.

The role requires a DABT certification and 10+ years in toxicology, with strong analytical and writing skills, and experience managing external laboratories. Travel <10% is expected.

Qualifications

• Bachelor's degree in Toxicology, Chemistry, Biology or related technical field.
• 10+ years of experience in Toxicology or a related field.
• Board certified toxicologist (DABT or equivalent) is required.
• Working knowledge of FDA QSR and EU Medical Device Regulations.
• Experience with ISO 10993/ISO 14971 and toxicological risk assessments.
• Knowledge of extractables and leachables (E&L) studies and analytical data interpretation.
• MS Word, Excel, Project and statistics software proficiency; strong communication skills.
• Preferred: Master’s or PhD with related field experience.

Responsibilities

• Lead biological evaluation planning (BEPs) and reports (BERs) per ISO 10993.
• Conduct toxicological risk assessments to support product development and regulatory submissions.
• Provide expertise on safe exposure levels for substances in Bracco products.
• Collaborate with R&D, Regulatory Affairs, and suppliers throughout lifecycle stages.
• Advise on biomedical safety in regulatory and legal contexts.
• Oversee external testing labs and manage cross-functional teams.
• Develop BEP/BER protocols and review reports for compliance.

Skills

Toxicology

Biocompatibility

Regulatory submissions

Communication

Technical writing

Independent work

Education

Bachelor's degree in Toxicology/chemistry/biology

DABT board certification

Master's degree (preferred)

PhD in Toxicology (preferred)

Tools

MS Word

MS Excel

MS Project

Statistical software

Job description

Bracco Medical Technologies seeks a Senior Scientist, Toxicologist to lead biocompatibility testing and risk assessments for Bracco medical devices. You will drive BEPs and BERs, ensure ISO 10993 compliance, and guide cross-functional teams on safety and regulatory submissions.

The role requires a DABT certification and 10+ years in toxicology, with strong analytical and writing skills, and experience managing external laboratories. Travel <10% is expected.