Sr Executive Post Market Surveillance

Vantive; Gurgaon; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Vantive is a vital organ therapy company expanding digital solutions and services to improve patient care. This role focuses on evaluating product quality complaints, owning complaint processing, determining reportability, and preparing regulatory submissions such as MDR/MIR.

You will monitor investigations, review evaluations across departments, and perform data queries to drive continuous improvements within the organization.

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

Job description

Job Description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. 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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

• 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.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

Requirements