Biocompatibility Specialist

Kelly Science, Engineering, Technology & Telecom provided pay range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

The Biocompatibility Specialist is responsible for planning, coordinating, and executing biological safety evaluations of medical device materials and products. Working within a cross‑functional team, the role ensures that devices meet international standards and regulatory requirements for biocompatibility, supporting both product development and regulatory submissions.

This position offers hands‑on exposure to ISO 10993 standards, laboratory testing, and risk assessment processes, with opportunities to collaborate with toxicologists, engineers, and regulatory teams.

• Plan and execute biological safety evaluations according to ISO 10993 and applicable regulatory requirements.
• Review product documentation related to materials, manufacturing processes, sterilization, packaging, and cleaning validation.
• Identify potential gaps in ISO 10993‑1 compliance and support testing requirements.
• Design, coordinate, and interpret laboratory investigations for biocompatibility testing.
• Ensure all testing complies with ISO, FDA, GLP, and other relevant regulatory standards.
• Compile, write, review, and approve Biocompatibility Test Plans, Test Reports, and Biological Safety Risk Assessments.
• Support regulatory submissions and preparation of technical files.
• Contribute to problem‑solving for complex biocompatibility or toxicological issues.
• Partner with R&D, Regulatory Affairs, Quality Engineering, Manufacturing, Packaging, and Project Teams to achieve project goals.
• Collaborate with internal scientists, toxicologists, and external laboratory consultants.
• Work cooperatively across disciplines to meet deadlines and ensure compliance.
• Drive problem resolution efficiently using analytical and problem‑solving skills.
• Demonstrate flexibility, adaptability, and commitment to continuous improvement.
• Maintain high standards of documentation, communication, and ethical conduct.

• Bachelor’s or Master’s degree in biology, chemistry, toxicology, microbiology, biomedical engineering, or a related scientific discipline.
• Minimum 2–5 years of industrial experience in biocompatibility evaluation within medical device, pharmaceutical, or regulated consumer product environments.
• Knowledge of toxicology, biological safety assessment, and coordination/interpretation of biocompatibility studies.
• Understanding of medical device manufacturing processes is preferred.
• Strong written and verbal communication skills in English.
• Ability to work collaboratively in a dynamic, multi‑functional environment.

• PhD with at least 1 year of industrial experience in biocompatibility evaluation.
• Familiarity with regulatory submissions and technical file preparation.
• Exposure to ISO 10993 testing coordination and laboratory management.
• Analytical thinking and problem‑solving skills.
• Attention to detail and quality focus.
• Proactive, self‑directed, and resilient under pressure.
• Ethical, transparent, and committed to teamwork.

• Associate

• Full‑time

• Manufacturing, Quality Assurance, and Science

• Staffing and Recruiting and Medical Equipment Manufacturing

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