Toxicologist R&D

Job Summary

Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs. This position is responsible for toxicological risk assessments and biological evaluations of medical devices, OTC, and cosmetic products in support of new and sustaining product development activities, as well as global regulatory submissions. This position ensures product safety and supports risk mitigation efforts in the form of biological evaluations, chemical characterization, and toxicological risk assessments. This position plays an important role in product development by helping ensure patient safety while supporting product design, regulatory compliance, and commercialization activities.

Responsibilities

• Provide strategic input for regulatory submissions (e.g., 510(k), CE marking, PMDA) and interact with global regulatory bodies.
• Author toxicological and/or biological assessments (Biocompatibility) for new and existing medical devices and/or cosmetic OTC products with their components and materials.
• Develop and implement strategies for biological evaluation to ensure compliance with global regulatory standards such as ISO 10993 and ISO 14971, for submissions to the FDA and EU MDR.
• Remain current and apply understanding of ISO 10993, ISO 18562, ISO 14971, FDA guidance, EU MDR, and other global regulatory guidance documents and pertinent quality system requirements.
• Review test protocols, test data, test reports, and overall technical assessments and interpret biocompatibility, chemical characterization, extractables/leachables, or in vivo safety testing results to support product safety claims and regulatory submissions.
• Conduct and interpret chemical characterization (e.g., E&L studies, ISO 10993-18, ISO 18562), SAR/QSAR modeling, and guide biocompatibility testing under GLP requirements.
• Serve as a technical resource to cross-functional teams including R&D, quality, and regulatory affairs, and advise on potential risks associated with product materials and processes.
• Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
• Contribute to continuous improvement of toxicology and biocompatibility processes, tools, and documentation practices.

Qualifications

• Education and Experience: Bachelor's degree in Toxicology, Pharmacology, or a related scientific field. 5+ years of experience in toxicology, with a significant focus on the medical device or a closely related industry (e.g., pharmaceutical, biotech) and toxicological risk assessments, biocompatibility assessments, and chemical characterization.
• Knowledge / Skills / Abilities: Knowledge of toxicology principles, risk assessment methodologies, and global regulations like ISO 10993, ISO 18562, ISO 14971, FDA, and EU MDR. Must possess excellent communication (written and verbal), and problem-solving skills with the ability to manage multiple projects simultaneously and work effectively.

Preferred Qualifications:

• A Diplomate of the American Board of Toxicology (DABT) or equivalent certification is highly desirable.
• Experience of quality audit by external regulatory bodies (FDA, EU Regulatory body, etc.).
• Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.
• Experience communicating with internal and external business partners and cross functional teams with various audiences.