Sr Executive, Post Market Surveillance

Vantive; Gurugram District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Vantive is a vital organ therapy company focused on extending lives through digital solutions and advanced services. The role involves evaluating quality complaints, authoring regulatory reports, and maintaining PMS per EU MDR to ensure patient safety and compliance.

You will work cross-functionally across Quality, Regulatory, and Engineering teams to drive timely resolutions, trend analysis, and continuous improvements within the organization.

Qualifications

• Experience with quality complaints handling under Quality System.
• Author and submit regulatory reports (MDR, MIR, etc.).
• Monitor complaint investigations and drive corrective actions.
• Review evaluations and investigations across multiple functions.
• Perform data queries for trend analysis and improvements.

Responsibilities

• Evaluate quality complaints and initiate records/actions within the Quality System.
• Own and process quality complaints per procedures.
• Determine and approve reportability assessments per procedures.
• Submit regulatory reports to authorities when required.
• Monitor investigations and drive closure of complaints.
• Review and approve evaluations and investigations of complaints.
• Provide complaint data via queries and trend analysis for improvements.
• Maintain Post Market Surveillance documents per EU MDR.

Skills

Quality management systems

Regulatory reporting

Post market surveillance

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or Biomedical Engineering

Tools

MS Office

Quality system software

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

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