Biocompatibility Scientist

A company is looking for a Biocompatibility Scientist to join their R&D Product Development team.

Key Responsibilities

Conduct biocompatibility and toxicology evaluations in compliance with ISO 10993 standards and global regulatory requirements

Lead impact assessments of manufacturing, supplier, and material changes related to product biocompatibility and safety

Collaborate with internal teams and external laboratories to plan, execute, and interpret biocompatibility testing

Qualifications & Skills

Bachelor's degree in biomedical engineering, biology, biochemistry, toxicology, analytical chemistry, materials science, or related field required; Master's degree preferred

5+ years of experience in biocompatibility assessment of medical devices

Extensive knowledge of ISO 10993 standards and experience applying them in a regulated environment

Experience with global regulations including FDA, EU MDR, and REACH

Strong project management skills with the ability to lead cross-functional teams