Senior Biocompatibility Scientist: FDA/ISO Regs Expert

Abbott; Los Angeles (CA); Presencial; USD 90 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health benefits

Tuition reimbursement

Retirement plan

Resumo da oferta

Abbott is seeking a Senior Biocompatibility Scientist at its Sylmar, CA location. You will act as a Subject Matter Expert in biocompatibility, ensuring patient safety across product life cycles and regulatory compliance with ISO 10993 and FDA guidance.

The role involves collaboration with global teams, regulatory submissions, and risk-based decision making. You will interpret regulatory requirements, review scientific data, identify gaps, and support strategy development for biocompatibility

Qualificações

• Bachelor's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or related field.
• 5+ years of industrial experience in Medical Device, Pharmaceutical, or Biotechnology fields.
• Fundamental understanding of ISO 10993 standards and biocompatibility methodologies.
• Option to upgrade to Senior II scientist based on candidate qualifications.

Responsabilidades

• Prepare and finalize biological evaluation safety plans and reports, synopses, regulatory documents and related biocompatibility documents.
• Analyze biocompatibility data to determine data adequacy and troubleshoot results.
• Review, approve and deliver biocompatibility assessments and reports within a risk-based framework.
• Collaborate with cross-functional teams to support multiple projects and regulatory submissions.

Conhecimentos

MS Office

Communication skills

Technical writing

Team collaboration

Time management

Cross-functional teams

Formação académica

Bachelor's in Biomedical Engineering

Master's degree preferred

Descrição da oferta de emprego

Abbott is seeking a Senior Biocompatibility Scientist at its Sylmar, CA location. You will act as a Subject Matter Expert in biocompatibility, ensuring patient safety across product life cycles and regulatory compliance with ISO 10993 and FDA guidance.

The role involves collaboration with global teams, regulatory submissions, and risk-based decision making. You will interpret regulatory requirements, review scientific data, identify gaps, and support strategy development for biocompatibility