Global Biocompatibility Director

RXinsider LTD.; Santa Clara (CA); On-site; USD 172,000 - 344,000; Full time

Job summary

Abbott is seeking a Director of Biocompatibility to lead global biological evaluation and materials safety for medical devices and combination products. The role directs teams of scientists and toxicologists, ensuring ISO 10993 compliance and regulatory readiness across geographies.

The position requires collaboration with R&D, Regulatory, and Manufacturing to drive safe, compliant product launches while engaging with regulators and external partners.

Qualifications

• Bachelor's degree in a relevant scientific field.
• Ph.D. or MS in Biology, Biomedical Engineering, Materials Science, Toxicology, or related discipline.
• 12+ years of experience in biocompatibility, toxicology, or materials safety within medical devices.
• 5+ years of leadership, managing scientific teams across sites.
• Proven track record leading programs supporting regulatory submissions.
• Strong expertise in US and global regulatory requirements for biocompatibility, ISO 10993.
• Experience with FDA and notified bodies interactions.
• Excellent scientific judgment and communication.

Responsibilities

• Provide strategic leadership for global biocompatibility and materials safety programs.
• Lead biocompatibility scientists across multiple sites with accountability.
• Ensure compliance with ISO 10993 and global regulatory guidance.
• Oversee evaluation plans, toxicology risk assessments, and testing strategies.
• Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure safety.
• Partner with cross-functional teams to enable safe product launches.

Skills

Biocompatibility

Toxicology

Regulatory strategy

Leadership

Global regulatory experience

Extractables & Leachables

ISO 10993

Scientific judgment

Communication

Cross-functional leadership

Education

Bachelor's degree

Ph.D. or MS in Biology, Biomedical Engineering, Materials Science, Toxicology, or related discipline

Job description

Abbott is seeking a Director of Biocompatibility to lead global biological evaluation and materials safety for medical devices and combination products. The role directs teams of scientists and toxicologists, ensuring ISO 10993 compliance and regulatory readiness across geographies.

The position requires collaboration with R&D, Regulatory, and Manufacturing to drive safe, compliant product launches while engaging with regulators and external partners.