Sr Executive, Product Surveillance

5 months ago

Gurugram, India Baxter Full time

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.

Summary:

Post-market surveillance involves collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings. The Post Market Surveillance Associate will be responsible for evaluating potential product quality complaints, initiating timely actions in association with coordinating the investigation to complaint closure. Ensure applicable, local, national and international regulatory requirements and internal expectations are met.

Essential Duties and Responsibilities:

Evaluate potential product quality complaints and initiate applicable records & actions within proper Quality System. Own and process quality complaint as per applicable procedures. Determine, facilitate and/or approves reportability assessments and decisions based on applicable procedures. Author and submit applicable regulatory reports (MDR, MIR, etc.) to competent authorities when deemed required. Monitor the status and progression of complaints under investigation and initiate actions to facilitate its resolution and closure. Review and approve the results of Engineering, Manufacturing, Quality, Service and/or Supplier evaluations and investigations of complaints. Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints to drive continuous improvements within the department and organization. Implement and maintain Post Market Surveillance documents (PMSP, PSUR, etc.) as per EU Medical Device Regulation. Performs other duties as needed and assigned.

Qualifications:

Excellent verbal and written communication skills. Analytical approach to problem solving. Ability to handle and manage workload independently Well organized and able to multitask effectively in a rapid paced environment, as well as show assertiveness, when interfacing with other personnel during the complaint handling process. Experience with Trackwise or equivalent complaint tracking system software and Microsoft Office and database skills are required. Knowledge of FDA/ ISO regulations and Country requirements. Knowledge of MDR and MDV reporting.

Education and/or Experience:

Bachelor’s Degree – Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.). Prior experience (2+ years) with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory. Experience with current U.S. FDA, EUMDR, MDD, ISO 13485, ISO9001, MDSAP and/or CMDR regulations, standards, and guidance documents (Preferred).

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