This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary:

Toxicologist supporting a diverse portfolio of medical devices for global registrations.  Apply a solid understanding of medical devices and device packaging toxicology requirements to support safety evaluations and preclinical regulatory submission content development. Design biological risk assessments/strategies for evaluating medical devices.  Monitor testing and interpret the results for project teams. Engage with global internal and external stakeholders to drive projects forward.

Essential Duties and Responsibilities:

Develop testing strategies such as the biological evaluation plan to qualify medical devices according to global guidelines.  Manage projects and coordinate safety testing for Baxter’s product portfolio. Review literature and identify relevant articles to support product development and registration.  Interpret data and develop justifications to address safety in alignment with ISO 10993-1 Develop preclinical regulatory submission content for DMF files, USA FDA 510 K Submission, EU MDR and global submissions. Address potential inquiries related to safety assessments (biocompatibility / toxicology risk assessments) submitted to FDA, EU notified bodies or global ministries of health. Implement the use of ISO 10993 series, regional pharmacopeia, 21 CFR Part 58 Good Laboratory Practices for Non-Clinical Studies, and/or regulatory guidance documents to qualify Baxter products. Perform preclinical change control impact assessments and work with cross functional team members (engineering, extractables and leachables, regulatory, etc.) to determine a comprehensive testing strategy. Mentor junior team members and review test strategies Oversee shipment of products to external contract laboratories

Qualifications:

The position requires relevant technical knowledge in biocompatibility/toxicology and general understanding of material physical and chemical properties. Ability to understand and apply global regulatory guidelines including OECD, FDA GLP, ISO 10993 series, USP pharmacopeia and regional compendia. Experience in working in global cross-functional teams and study monitoring. Critical thinker with intellectual self-assurance and courage.  Independent problem solver who can use a methodical approach to develop solutions and make recommendations. Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met. Can effectively communicate with internal and external stakeholders. Excellent attention to detail. Good oral and written communication in English. Multilingual desired for communication with global teams highly desired but not required (i.e. Spanish, French, Italian, German). Software knowledge of Siemens Teamcenter Unified, Microsoft Office, Trackwise, and Documentum based systems, recommended. DABT or eligible highly desired

Education and/or Experience:

• Bachelor's degree in a scientific discipline with 15 years of relevant experience.

• MS with at least 10 years experience, or PhD with at least 3-4 years of relevant experienced required.

• Lab experience includes research in GLP/GMP environment, leadership of technical teams, and project

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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