Toxicology Consultant with FDA CDRH Experience Needed

• *Job Description:** We are actively seeking a highly experienced and knowledgeable toxicology consultant to provide expert guidance and support on the preparation of a pre-IDE work plan for a novel compound to be submitted to FDA's Center for Devices and Radiological Health (CDRH). This position is critical as we strive to ensure that our medical devices and diagnostic products meet the highest standards of safety and efficacy in accordance with regulatory requirements set forth by the FDA. The ideal candidate will possess a robust and proven track record in conducting toxicological assessments specifically related to medical devices and diagnostics. Your deep understanding of toxicological principles, combined with your experience in regulatory submissions, will be invaluable in guiding our team through the complexities of the regulatory landscape. You will be instrumental in developing strategies to address potential toxicological concerns and ensuring that all products adhere to FDA standards. In this role, you will be responsible for defining preclinical and clinical work required as part of a pre-IDE package, evaluating and interpreting toxicological data, identifying potential risks, and providing clear recommendations based on your findings. Strong analytical skills are essential, as you will be required to critically assess data from various sources and communicate your insights effectively to both technical and non-technical stakeholders. Your ability to synthesize complex information into actionable strategies will be key to our success. In addition to your technical expertise, we are looking for a candidate who is proactive, detail-oriented, and possesses excellent communication skills. You will work collaboratively with cross-functional teams, including R&D, regulatory affairs, and quality assurance, to ensure that all aspects of product development incorporate sound toxicological principles. As part of our commitment to enhancing the safety and effectiveness of our diagnostic products, you will also have the opportunity to stay updated on the latest advancements in toxicology and regulatory science, contributing to the continuous improvement of our processes and product offerings. Your insights will not only support compliance but also drive innovation in our product development initiatives. If you are passionate about toxicology and excited about the opportunity to make a meaningful impact in the field of diagnostics, we encourage you to join our team. Together, we can work towards advancing the safety and efficacy of medical devices that improve patient outcomes and contribute to public health. Apply tot his job Apply tot his job