Biocompatibility Specialist

Biocompatibility Specialist

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.

Key Responsibilities:

Biological Safety & Biocompatibility:

• 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

Technical Documentation & Regulatory Support:

• 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

Cross-Functional Collaboration:

• 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

Continuous Improvement & Professional Excellence:

• 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

Required Qualifications & Experience:

• 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

Preferred Experience:

• 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

Key Competencies:

• 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