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 Now
Apply Now
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 Now
Apply Now