Biocompatibility Specialist

Kelly Science and Clinical FSP is currently seeking a Junior Biocompatibility Specialist for a long-term engagement with one of our Global Medical Device clients. This position is remote. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time. 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 2–3 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 Posted By: Lea Lolley Apply tot his job