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Join Baxter in our mission to save and sustain lives by developing Infusion Systems products. As a Principal Compliance Engineer, your responsibilities will include, ensuring our products are designed to meet regulatory standards, ensuring compliance requirements are properly cascaded to subsystems and risks mitigated by working with talented engineers and partnering with certification agencies to certify our products. Ensures Infusion Systems hardware solutions comply with applicable standards. Collaborate with design engineers to develop product requirements that comply with standards and regulations for intended global markets. Cascade system compliance requirements to subsystem requirements to ensure overall design for compliance. Develop Compliance Plans, participate in design and development activities (Technical Reviews and Design Reviews) and resolve product certification, compliance and safety issues. Develop product certification strategy and resolve compliance issues for complex medical devices. Ensures compliance with product related environmental regulations (e.g. REACH, RoHS). Keep abreast of changes to product standards and regulations affecting medical products. Work with Verification team to review compliance testing plans to ensure compliance to recognized standards and test methods. Submit documentation to certification bodies and regulatory authorities as required to obtain product certifications. Demonstrated experience working with product standards and their global variants.
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