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Post Market Surveillance Associate

Req # JR - 023167 Location Gurgaon, Haryana, India Additional Locations 48 Job Category Quality Control Date posted 07/30/2020

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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.

·Implementation of the Post Market Surveillance requirements as part of the EU Medical Device Regulation including:

oGap assessment of current processes and regulation requirements;

oImplementation of new requirements that align and support peripheral teams and processes;

oImplementation and maintenance of the Periodic Safety Update Report (PSUR);

oImplementation and maintenance of the Post Market Surveillance Plan;

oImplementation and maintenance of the Post Market Surveillance Report;

oCollaboration with cross-functional teams to support EU MDR requirements, escalations, and updates.

·Analyze complaint and product failure data;

·Participate and/or Lead Active Market Surveillance activities (i.e. surveys, etc.).

·Provide feedback and escalate any concerns or issues within the process.

·Support execution and improvements to the current PMS processes.

·Pro-actively recognizes and identifies current and future problems, structures them and quickly translates them into solutions and opportunities.

·Execute on projects as required by Manager.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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