.**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.Overall Purpose of the role:Reporting to the PMS/Quality Manager and acting as a key member of the International QA Department. The MDR Specialist is responsible for ensuring that Hillrom meets its Regulatory reporting requirements and aligning the teams with a consistent, one Hillrom, global approach to reportable events.Principal Duties/ Responsibilities:1. Review decision-trees and other supporting information in Hillroms Complaint System, in order to determine rationale or decision on whether incidents are reportable as per applicable Regulations in conjunction with the Global Potential Reportable Event (PRE) Team. Document rationales/reporting decisions and challenge decisions where necessary and advise PMS QA Manager wherever appropriate.2. Prepare and file Initial and Final Device MDR Reports, as required, for all Incidents deemed reportable in accordance with reporting timeframes.3. Liaise with all key stakeholders, (customers, distributors, customer facing teams, service teams, in-country QA personnel etc), to acquire additional information/clarification, as needed, to determine decision on reportability.4. Liaise with Competent Authorities & Notified Bodies on additional information requests with a view to getting closure on MDRs.5. Contribution towards the improvement and awareness of all post market vigilance system process activities across all departments throughout Hillrom. Interfacing with other departments and functions, including Operations, Customer Care, Service, Sales and Marketing. Actively seek feedback from internal customers and team members regarding issues and escalate relevant issues to the appropriate people to create an environment of continuous improvement and service excellence. Consult on and identify opportunities for improving the operation of all aspects of the company's post market vigilance system process activity.6. Regularly report relevant updates to the team and manager. Proactively seek to keep up-to-date with all information relating to ongoing corporate post market vigilance system process activities and all relevant internal tools, processes, procedures and working practices