Sr Executive, Post Market Surveillance

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.

Implementation of the Post Market Surveillance requirements as part of the EU Medical Device Regulations including:

o Gap assessment of current processes and regulation requirements;

o Implementation of new requirements that align and support peripheral teams and processes;

o Implementation and maintenance of the Periodic Safety Update Report (PSUR);

o Implementation and maintenance of the Post Market Surveillance Plan;

o Implementation and maintenance of the Post Market Surveillance Report;

o Collaboration with cross-functional teams to support EU MDR requirements, escalations, and updates.

Enter complaint information within complaint database;

Analyze complaint and product failure data;

Participate and/or Lead Active Market Surveillance activities (i.e. surveys, etc.).

Provide feedback and escalate any concerns or issues within the process.

Support execution and improvements to the current PMS processes.

Pro-actively recognizes and identifies current and future problems, structures them and quickly translates them into solutions and opportunities.

Execute projects as required by Manager.

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

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