Senior Biocompatibility Scientist – ISO 10993 Expert

AbbVie; New Jersey; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Medical/Dental/Vision Insurance

401(k)

Job summary

AbbVie is seeking a Sr Scientist I - Biocompatibility to lead biocompatibility evaluations for marketed medical devices, including global change-control activities and regulatory documentation. You will collaborate with cross-functional teams and sites to ensure compliant, timely assessments and provide technical training.

The role emphasizes ISO-10993 expertise, quality systems, and strong technical writing, with opportunities to influence product lifecycle decisions and regulatory responses

Qualifications

• Bachelor’s Degree in Life Science or related field with 10+ years in a scientific role in the medical device or pharma industry; Master’s with thesis and 8+ years in a scientific role.
• Experience in regulated environments with proven success supporting marketed products and change control processes.
• Significant experience with medical device and combination product regulations; strong technical writing and communication skills.
• Knowledge of ISO-10993 Standards, FDA Guidance/Regulations, and Animal Welfare Regulations.

Responsibilities

• Lead biocompatibility change control activities for marketed products across global sites.
• Develop and deliver biocompatibility training for internal stakeholders.
• Generate documentation for regulatory submissions and responses.
• Provide cross-functional project support and interface with CROs when needed.

Skills

Technical writing

Regulatory compliance

ISO-10993

Change control

Cross-functional teamwork

Education

Bachelor’s Degree in Life Science

Master’s Degree in Life Science

Tools

Electronic Data Management Systems

Microsoft Office

Job description

AbbVie is seeking a Sr Scientist I - Biocompatibility to lead biocompatibility evaluations for marketed medical devices, including global change-control activities and regulatory documentation. You will collaborate with cross-functional teams and sites to ensure compliant, timely assessments and provide technical training.

The role emphasizes ISO-10993 expertise, quality systems, and strong technical writing, with opportunities to influence product lifecycle decisions and regulatory responses