Senior Biocompatibility Scientist: Regulatory Strategy

Abbott (abbottcareers2 board); United States; On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

HIP PPO medical plan

Generous retirement plan

Tuition reimbursement

FreeU education benefit

Career development opportunities

Job summary

Abbott is seeking a Senior Biocompatibility Scientist in Sylmar, CA to support biocompatibility of medical devices, materials, and processes. You will represent the Global Biocompatibility Group as SME and ensure compliance with ISO 10993 and related FDA guidance across product lifecycles.

You will interpret regulatory requirements, support strategy, and review test plans and risk assessments. Strong collaboration with cross-functional teams is essential.

Qualifications

• Proficient in MS Word, Excel, PowerPoint, Outlook and SharePoint.

Responsibilities

• Prepare and finalize biological evaluation safety plans and reports, synopses and regulatory documents.
• Analyze biocompatibility test results and troubleshoot issues.
• Review and deliver biocompatibility assessments and reports per FDA/ISO guidance.
• Collaborate with cross-functional teams to support multiple projects.
• Assist regulatory submissions addressing biocompatibility strategy.

Skills

MS Office proficiency

Verbal & written communication

Technical writing

Team collaboration

Organizational skills

Job description

Abbott is seeking a Senior Biocompatibility Scientist in Sylmar, CA to support biocompatibility of medical devices, materials, and processes. You will represent the Global Biocompatibility Group as SME and ensure compliance with ISO 10993 and related FDA guidance across product lifecycles.

You will interpret regulatory requirements, support strategy, and review test plans and risk assessments. Strong collaboration with cross-functional teams is essential.