Biocompatibility Scientist

Biocompatibility Scientist (100% Remote) Pay Rate: $120.00 – $150.00 per hour (W2) Location: Remote (Client HQ: Gainesville, FL – No relocation required) Job Summary We are seeking an experienced Biocompatibility Scientist to lead, plan, and execute biological safety evaluations for medical devices in alignment with the ISO 10993 series. This role supports product safety across the entire product lifecycle—new product development, sustaining engineering, and supplier/material change initiatives. The ideal candidate has strong expertise in biocompatibility test strategies, chemical characterization, toxicological risk assessment, and regulatory compliance for medical devices. Key Responsibilities • Develop and implement biocompatibility evaluation strategies for new products, product updates, and material changes. • Manage and oversee multiple biocompatibility projects simultaneously, ensuring timely completion and escalation of risks when needed. • Lead biological safety assessments per ISO 10993 standards, providing scientific justification and objective evidence supporting product safety. • Partner with cross-functional teams—including Regulatory Affairs, Clinical Affairs, R&D, QA, and Manufacturing Engineering—to ensure compliance and support project timelines. • Facilitate and coordinate laboratory activities such as: • Chemical characterization • Toxicological risk assessments • Biological testing • Lab investigations • Review, interpret, and summarize complex data into Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER). • Serve as a Subject Matter Expert (SME) for biocompatibility during regulatory submissions and interactions with FDA, BSI, and other competent authorities. • Ensure compliance with applicable Quality Systems, FDA regulations, and international biological safety standards. Required Qualifications • Bachelor’s, Master’s, or Ph.D. in Biology, Biomedical Engineering, Toxicology, Materials Science, or related field. • Strong experience with ISO 10993 standards and biocompatibility assessments for medical devices. • Proven ability to interpret scientific data, drive testing strategies, and prepare compliant documentation. • Experience collaborating with regulatory bodies and supporting regulatory submissions. • Excellent communication, scientific writing, and project management skills. Preferred Qualifications • Experience in orthopedic, implantable, or Class II/III medical devices. • Background in toxicological risk assessments and chemical characterization techniques. • Prior SME experience supporting audits or regulatory reviews. Apply tot his job Apply To this Job