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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Biocompatibility Specialist

Raynham, MA

Full-time

Onsite

Entry, Mid Level

$110K/yr - $117K/yr

2+ years exp

Kelly Science, Engineering, Technology & Telecom is seeking a Biocompatibility Specialist responsible for planning, coordinating, and executing biological safety evaluations of medical device materials and products. The role involves ensuring compliance with international standards and regulatory requirements while collaborating with cross-functional teams.

Staffing & Recruiting

Hiring Manager

Lea Lolley

Responsibilities

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

Qualification

ISO 10993 standardsBiocompatibility evaluationToxicology knowledgeRegulatory submissionsLaboratory testingAnalytical thinkingCommunication skillsProblem-solving skillsAttention to detailTeamwork

Required

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