RegulatoryAffairsSpecialist-TemporaryRole

**This is where** your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. **WHAT YOU 'LL BE DOING: ** * Provide regulatory input to new product development and product lifecycle planning mainly for Global Surgical Solutions product portfolio (Operating Lights, Operating Tables and Accessories) * Generation of documentation and procedures relating to product development, manufacturing, and quality control in accordance with regulatory standards * Ensure compliance with regulations (e.g. 21 CFR 820, MDR), standards (ISO 13485), and the quality manual and internal procedures. * Work closely with product development, clinical, and marketing teams to gain required information for new product submissions and provide regulatory advice to project teams as required (Example: DHF/Technical Documentation maintenance) * Review documents, including Clinical Evaluation reports, risk analysis, FMEA, reports, labeling, advertising, promotion and marketing literature * Assist with document control, including document review, approval, archiving, maintenance of document list, and working with other functional groups on development of new processes or procedures * Maintain regulatory files in a format consistent with requirements * Assess the acceptability of quality, preclinical and clinical d