Principal Specialist, Regulatory Affairs (Medical Device)

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.  Job Summary  This role is responsible for providing regulatory support for on-market products.  You will independently plan, organize and execute, activities including change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams. You will help accelerate the design and development cycle by collaborating across cross functional teams. Will be guiding, supporting and mentoring the team who are part of engineering design, development, verification & validation. This position is based out of Bangalore and reporting to the Manager – Systems - Patient Support Systems and Global Surgical Solutions divisions. You will need to work collaboratively with cross functions research & development teams.     What you’ll be doing  Review and provide regulatory impact assessments for changes Support global submission deliverables for product variation submissions Responsible for working with other parts of the regulatory organization to achieve desired results. Execute global plans and regulatory submission deliverables for sustaining variations Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results Ensure identified standards and content requirements are met for regulatory submissions Timely, actively support query responses Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s). Maintain regulatory files in a format consistent with requirements Tracking of status, quality/compliance and progress of regulatory documentation Review, edit and proofread regulatory documentation Work closely with product development, clinical, and marketing teams to gain required information for new product submissions and provide regulatory input to project teams as required (Example: Design History File (DHF) remediation, labeling guideline) Assist with the review…