Post Market Surveillance Trainee Specialist

3 weeks ago

Gurgaon, Haryana, India Baxter Full time

Vantive: A Revolutionary Kidney Care Company


Baxter is embarking on a groundbreaking journey to separate our ~$5B Kidney Care segment into a standalone company, Vantive.
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 patients worldwide.


Key Responsibilities:



  • Evaluate potential product quality complaints and initiate timely actions in association with coordinating the investigation to complaint closure.
  • Own and process quality complaint as per applicable procedures.
  • Determine, facilitate and/or approve 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.
  • Perform 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.
  • Perform other duties as needed and assigned.

Requirements:



  • 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).

 


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.


Vantive will 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.


 


Key Skills:



  • Regulatory compliance, quality assurance, and post-market surveillance.
  • Excellent written and verbal communication skills.
  • Strong analytical and problem-solving skills.
  • Ability to multitask and manage workload independently.
  • Experience with Trackwise or equivalent complaint tracking system software.

 


At Vantive, we believe in the importance of our legacy and the impact we can have on patients' lives.


We are committed to delivering best-in-class care and services to our patients.


 


Join us in our mission to revolutionize kidney care and other vital organ support.


 


Together, we can make a difference in the lives of patients worldwide.


 


Apply today and become part of a community that is focused, courageous and driven to make a difference.


 


As a Post Market Surveillance Associate at Vantive, you will be responsible for evaluating potential product quality complaints, initiating timely actions in association with coordinating the investigation to complaint closure.


 


You will be part of a team that is dedicated to delivering best-in-class care and services to our patients.


 


Key Responsibilities include:



  • Evaluate potential product quality complaints and initiate timely actions in association with coordinating the investigation to complaint closure.
  • Own and process quality complaint as per applicable procedures.
  • Determine, facilitate and/or approve 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.
  • Perform 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.
  • Perform other duties as needed and assigned.

 


Requirements include:



  • 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.

 


Apply today and become part of a community that is focused, courageous and driven to make a difference.


 


Together, we can make a difference in the lives of patients worldwide.


 


Vantive is committed to delivering best-in-class care and services to our patients.

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