Kelly Science and Clinical FSP is currently seeking a 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 2-5 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
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