MDR Project Manager (f/m/d)

at  Baxter

VANTIVE: A NEW COMPANY BUILT ON OUR LEGACY

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

• Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

YOUR ROLE AT BAXTER

As part of the Worldwide Medical (WWM) department you will be responsible for managing the execution and successful on-time completion of medical device deliverables that are required for CE-marking in the EU and Rest of World (ROW) for our Kidney Care Business.

WHAT YOU’LL BE DOING

• Facilitates communication between the WWM-Strategy & Delivery Team, product teams, and the Medical Writer (internal or external vendor) to ensure successful, on-time completion of the following deliverables:
• Clinical Evaluation Plans (CEP)
• Clinical Evaluation Reports (CER)
• Post-Market Clinical Follow-up Plans (PMCFP)
• Post-Market Clinical Follow-up Reports (PMCFR)
• Post-Market Clinical Follow-up L2 activities
• Summary of Safety & Clinical Performance (SSCP)
• Manages the successful completion of above deliverables for the creation of new deliverables, e.g. new product development of geographic expansion
• Partners with cross functional business partners, such as WWM-Medical Affairs, Post Market Surveillance, Product Quality, Research & Development, Regulatory Affairs, Global Patient Safety and potentially external vendors
• Responsible to drive the effort in successfully delivering the required documents by the required timelines; If anything places that delivery at risk, collaborates with cross functional business partners to mitigate that risk and anticipates potential deliverable schedule conflicts
• Implements an effective communication model with cross functional team members that provides deliverable status updates and supports timely completion of deliverables

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

• Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions