Executive, Post Market Surveillance at Vantive

Gurgaon, haryana, India -

Full Time

Start Date

Immediate

Expiry Date

18 Sep, 26

Salary

0.0

Posted On

20 Jun, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Post Market Surveillance, Complaint Handling, Regulatory Reporting, Data Analysis, Quality Systems, MDR Reporting, MIR Reporting, Trend Analysis, Problem Solving, Technical Writing, Attention To Detail, Multitasking

Industry

Medical Equipment Manufacturing

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. Job Summary: Post-market surveillance involves collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings. The Post Market Surveillance Trainee 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 and 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.· Performs other duties as needed and assigned. Qualifications: Demonstrate a high level of motivation and proactive personality. Excellent verbal and written communication skills. Display attention to detail to ensure accuracy in complaint documentation and regulatory reporting. Maintain a customer- and patient-focused attitude to handle complaints with empathy and professionalism. Analytical approach to problem solving. Exhibit ability to handle workload independently and work collaboratively within a team. 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. Demonstrate the ability to meet deadlines consistently. Education and/or Experience: Bachelor’s Degree or equivalent – Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.). Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. At Vantive, your work will expand your skills, knowledge and opportunities for growth and learning to advance your career. In 2023, we began the journey to establish Baxter’s chronic kidney care and acute therapies businesses into one standalone company. We are thrilled to introduce you to Vantive. Together, we 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 1+ million people we serve. At Vantive, we believe in not only building our leadership in the kidney care space, but offering meaningful work to those who join us. We offer a range of exciting career opportunities across various departments, from research and development to marketing and sales. If you are looking to drive innovation and growth at a new, purpose-driven organization, we have a place for you at Vantive.

Responsibilities

The role involves evaluating product quality complaints and managing them through to closure within the Quality System. It also requires authoring regulatory reports and performing trend analysis to drive continuous organizational improvements.