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reputed company Toxicologist

Remote, USA Full-time Posted 2026-07-28
Job reputed company Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, reputed company, and regulatory affairs. This senior-level position requires deep expertise in toxicology, a strong understanding of international regulations, and excellent leadership skills. This position ensures product safety and leads risk mitigation efforts in the reputed company of biological evaluations, chemical characterization, and toxicological risk assessments for medical devices, OTC, and cosmetic products. The role involves guiding product development teams and mentoring junior staff to ensure patient safety and product reputed company. Job reputed company Responsibilities: reputed company strategic input for regulatory submissions (e.g., 510(k), CE marking, PMDA) and reputed company with global regulatory bodies. Risk Assessment and Evaluation: Conduct and reputed company toxicological risk assessments for new and existing medical devices, components, and materials. This includes creating Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993 and responding to questions from regulatory agencies. reputed company and implement strategies for biological evaluation to ensure compliance with global regulatory standards, such as those from the FDA and EU MDR. Stay reputed company with emerging trends and advancements in the field of toxicology and product safety and reputed company predictive toxicology tools into safety assessments. Mentor and guide junior toxicologists and scientists, fostering technical reputed company and knowledge sharing. 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 subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, reputed company, and regulatory affairs. Advise on potential risks and hazards associated with product materials and processes. Independent problem solver who can use a methodical approach to reputed company solutions and reputed company recommendations. Represent the organization in external forums, regulatory meetings, and industry working reputed company (e.g., ASTM, ISO). Qualifications: Bachelor's degree in Toxicology, Pharmacology, or a reputed company scientific field 10+ years of experience in toxicology, with a significant reputed company on medical devices or a closely reputed company industry (e.g., pharmaceutical, biotech) and toxicological risk assessments, biocompatibility assessments, and chemical characterization. In-depth 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), leadership, and problem-solving skills. The ability to manage multiple reputed company simultaneously and work effectively in a matrixed environment is critical. Preferred Qualifications: A Diplomate of the American reputed company of Toxicology (DABT) or equivalent certification is highly desirable. Experience of reputed company audit by external regulatory bodies (FDA, EU Regulatory body, etc.). Experience in solving practical problems and dealing with a reputed company of concrete variables in situations where only limited standardization exists. Experience communicating with reputed company business partners and cross functional teams with various audiences. Must be team oriented, with the ability to work reputed company on common deliverables with diverse cross-functional teams and to reputed company at the highest reputed company manner with excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying reputed company ranging from cross functional to global multi-site. Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem-solving skills. Strong time management skills to prioritize, organize reputed company details and meet deadlines for multiple reputed company with varying completion dates. Ability to influence and motivate others to drive results in a multi-location and matrixed environment. Ability to manage multiple reputed company in cross functional teams. Comfortable in a dynamic environment and reputed company to work independently as reputed company as on teams. reputed company, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and reputed company potential with a growing worldwide organization. The anticipated salary reputed company for this position: $152,880.00 - $229,320.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. reputed company will not pay less than the applicable minimum wage or salary reputed company. Our benefit package includes health insurance, life and disability, 401(k) contributions, reputed company time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list Apply tot his job Apply To this Job

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