Senior Toxicologist

Job Title Senior Toxicologist Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 75,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most. The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. In this role, you have the opportunity to: Author scientifically rigorous Toxicological Risk Assessments (TRAs) class II/III medical devices, leveraging analytical and biological testing data to ensure compliance with ISO 10993 and ISO 18562 standards. Support regulatory submissions, design modifications, and field-related issue assessments. Support the design, monitoring, and interpretation of in vitro and in vivo biocompatibility studies, as well as chemical characterization studies, including volatile organic compounds (VOCs) and extractables & leachables (E&L). Collaborate closely with Biological Safety Engineers, Materials Scientists, and other cross-functional stakeholders to evaluate and select safe, optimal materials for the intended patient population. Support regulatory submissions, including drafting strategic responses to agency inquiries and preparing technical reports and documentation for pre-submissions Proactively update and maintain toxicology and biocompatibility-related QSPs, WIs, and templates/forms to ensure alignment with evolving regulatory expectations and internal requirements. Identify opportunities to enhance team capabilities; develop and deliver toxicology programs to strengthen competency and foster a collaborative, peer-review-driven team environment. Author and contribute to posters, publications, and manuscripts, and actively represent Philips at scientific conferences and AAMI working groups. This position is based in Pune-India You are a part of: Philips’ Sleep & Respiratory Care is dynamic Healthcare Technology organization that designs and develops life-saving Respiratory Care products. At Philips, we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Our tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in Respiratory Care   You're The Right Fit If: You hold a Master’s degree or Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline, with at least 5-10 years of relevant experience . Board Certification in Toxicology (e.g., DABT) is highly preferred. You have proven, hands-on experience authoring rigorous Toxicological Risk Assessments (TRAs). Experience with TRAs from industries beyond medical devices is also welcomed. You possess a comprehensive understanding of toxicology principles, risk assessment methodologies, and relevant standards (i.e. EPA, ATSDR, OEHHA, REACH, ICH, CIR, RIFM…) and comprehensive knowledge of ISO 10993, and ISO 18562. You have strong chemistry expertise, enabling clear interpretation of extractables and leachables (E&L) and VOC chemical characterization data. You demonstrate exceptional technical writing with the ability to translate complex analytical and biological data into clear technical memos, scientific publications, and compliant Quality Management System (QMS) documentation (e.g., QSPs, WIs). You bring strong cross-functional project management skills, with a demonstrated ability to independently manage multiple concurrent