Senior Biocompatibility Scientist – ISO 10993 Leader

Thornton Tomasetti; California; Hybrid; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

FreeU education benefit

Retirement plan

Job summary

Abbott Laboratories in Sylmar, CA seeks a Senior Biocompatibility Scientist to support biocompatibility for medical devices, materials, and processes. You will act as a SME within the Global Biocompatibility Group and collaborate with cross-functional teams to ensure regulatory compliance.

The role focuses on interpreting ISO 10993, guiding development and change activities, and reviewing safety data to support FDA/Notified Body submissions.

Qualifications

• Bachelor's degree in Biomedical Engineering, Biomed/Materials/biochem are relevant
• 5+ years industrial experience in Medical Device, Pharmaceutical or Biotechnology fields
• Fundamental understanding of ISO 10993, biomaterials, toxicological risk assessment
• Experience writing biological risk assessments for FDA and Notified Bodies

Responsibilities

• Prepare, edit, and finalize biological evaluation safety plans and reports, synopses, regulatory documents and related biocompatibility documents.
• Analyze biocompatibility test results to determine data adequacy and troubleshoot results.
• Review and deliver biocompatibility assessments and reports in compliance with FDA/ISO guidance.
• Regulatory submissions support and risk-based decision making.

Skills

MS Office

Strong communication

Technical writing

Team collaboration

Time management

Cross-functional experience

Education

Bachelor's degree in Biomedical Engineering

Master’s degree preferred

Tools

MS Office

Job description

Abbott Laboratories in Sylmar, CA seeks a Senior Biocompatibility Scientist to support biocompatibility for medical devices, materials, and processes. You will act as a SME within the Global Biocompatibility Group and collaborate with cross-functional teams to ensure regulatory compliance.

The role focuses on interpreting ISO 10993, guiding development and change activities, and reviewing safety data to support FDA/Notified Body submissions.