Kelly Science, Engineering, Technology & Telecom · 8 hours ago
Junior Biocompatibility Specialist
United States
Contract
Remote
Entry Level
$90K/yr - $115K/yr
2+ years expKelly Science, Engineering, Technology & Telecom is seeking a Junior Biocompatibility Specialist who will be 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
Required
Bachelor's or Master's degree in biology, chemistry, toxicology, microbiology, biomedical engineering, or a related scientific discipline
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
Strong written and verbal communication skills in English
Ability to work collaboratively in a dynamic, multi-functional environment
Preferred
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
Biocompatibility scientist, SME or study director
Ideally, experience with orthopaedic devices, Implants and surgical instruments
Experience in authoring Test plans, Test report, biological risk assessments
Big plus: Experience in drafting hazard assessment and toxicological risk assessment
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
Company data provided by crunchbase