Biocompatibility Change Leader — Regulatory & Training

AbbVie; New Jersey; On-site; USD 120,000 - 170,000; Full time

Job summary

AbbVie is seeking a Sr Scientist I - Biocompatibility to lead biocompatibility evaluations for marketed medical devices. You will interface with global manufacturing sites to drive change control, ensure regulatory compliance, and deliver high-quality documentation.

You will develop training for internal stakeholders, work with cross-functional teams, and support development projects as needed. Strong writing and regulatory knowledge are essential for success.

Qualifications

• Requires knowledge of ISO-10993 standards and medical device regulations.
• Experience in regulated environments with marketed products is preferred.
• Strong technical writing and communication skills are essential.

Responsibilities

• Lead global biocompatibility change-control activities across sites.
• Support ISO 10993 gap assessments and regulatory impact analyses.
• Develop and deliver biocompatibility training for internal stakeholders.
• Generate documentation for regulatory submissions and responses.

Skills

Biocompatibility

Regulatory compliance

Technical writing

Training

Project management

Education

Bachelor’s degree

Master’s degree

PhD

Tools

Change management platforms

Electronic Data Management Systems

Microsoft Office

Job description

AbbVie is seeking a Sr Scientist I - Biocompatibility to lead biocompatibility evaluations for marketed medical devices. You will interface with global manufacturing sites to drive change control, ensure regulatory compliance, and deliver high-quality documentation.

You will develop training for internal stakeholders, work with cross-functional teams, and support development projects as needed. Strong writing and regulatory knowledge are essential for success.