Vantive: A New Company Built On Our Legacy

 

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. 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 the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we 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.

Essential Duties and Responsibilities. 

Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions.Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals & submissionsTrack status and progress of regulatory documentationCoordinate and compile responses to regulatory authority questions (under supervision)Use an electronic document management system to compile documents to support submissions to Health AuthoritiesAnswer internal queries for assigned productsMaintain Database of Regulatory Requirements for renewalsSupport other regulatory processes as required, including device establishment registration, drug listing, structured product labeling, and processing requests for certificates and legalization.

Qualifications. 

Knowledge of regulationsScientific knowledgeAdministrative and project management skillsAbility to contribute to multiple projects from a regulatory affairs perspectiveAbility to multitask and prioritizeInterpersonal and communication skillsTechnical system skills (e.g. word processing, spreadsheets, databases, online research)Proofreading and editing skillsAbility to independently identify compliance risks and resolve or escalate as necessary

Education and/or Experience. 

6 + years of regulatory experience within a healthcare environment.

Bachelor’s degree or country equivalent in a relevant scientific discipline.
Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification.

Reasonable Accommodations

Baxter 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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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.