Senior Toxicologist

Senior Toxicologist

Requirements

• Extensive experience in toxicological risk assessment and medical device safety evaluations.
• Proven knowledge of biocompatibility testing methodologies and regulatory frameworks (ISO 10993, FDA, EU MDR, etc.).
• Demonstrated expertise in designing, conducting, and interpreting toxicology and biocompatibility studies.
• Proven ability to work cross-functionally and effectively communicate toxicological findings to technical and non-technical audiences.
• Experience working with regulatory bodies and preparing toxicology-related regulatory documentation for Class III devices.
• Proven analytical and problem-solving skills with attention to detail and scientific rigor.
• Excellent written and verbal communication skills.
• Master’s degree in Toxicology, Biomedical Science, or a related field with 5+ years of experience in toxicological risk assessment and biocompatibility evaluation, preferably in the medical device industry.
• OR Ph.D. in Toxicology, Biomedical Science, or a related field with 2+ years of experience in the same areas.

Responsibilities

• Conduct and oversee toxicological risk assessments for medical devices and materials to ensure compliance with ISO 10993 standards and global regulatory requirements.
• Manage biocompatibility and chemical characterization studies, collaborating with contract research organizations (CROs) to design, plan, and interpret toxicological testing.
• Evaluate potential toxicological hazards of new materials, manufacturing processes, and device modifications.
• Provide guidance on material selection, ensuring the use of safe and biocompatible materials in product development.
• Support regulatory submissions by preparing toxicological safety assessments and responding to regulatory inquiries.
• Stay abreast of emerging toxicological methodologies, computational toxicology models, and regulatory updates to improve risk assessment approaches.
• Act as a subject matter expert and mentor within the organization, educating internal teams on toxicological and biocompatibility considerations.
• Collaborate with engineering, supplier quality, and manufacturing teams to ensure toxicological compliance from design to commercialization for class III medical devices.
• Participate in scientific conferences, regulatory meetings, and industry working groups to contribute to the advancement of toxicology practices in the medical device industry.

Preferred Qualifications

• Experience with computational toxicology and in silico modeling.
• Expertise in extractables and leachables (E&L) assessments for Class III devices.
• Familiarity with Good Laboratory Practices (GLP) and regulatory compliance strategies.
• Knowledge of advanced analytical techniques (e.g., mass spectrometry, chromatography) for chemical characterization.
• Experience with engaging directly with regulatory authorities for toxicological discussions.
• Exceptional project management skills with the ability to drive multiple initiatives simultaneously.