RA Specialist (Fixed-Term Contract)

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.

Summary

Are you seeking meaningful work? One that empowers you to truly leave your mark? Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. The future 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.

Join our Regulatory Affairs global team!

Under supervision, you'll be responsible for the global coordination and preparation of documents/packages for regulatory submissions.

What you'll be doing

• Supports regulatory project plan execution;
• Maintain awareness of regulatory requirements and ensure continued learning;
• Maintain regulatory files in a format consistent with requirements;
• Participate as an active team member of project teams as required;
• Compile and prepare responses to questions from regulatory authorities according to plan;
• Edit and proofread regulatory documentation;
• Assist in preparation and review of labeling, SOP’s, and other departmental documents;
• Compile under supervision regulatory documents for submission;
• Track status and progress of regulatory documentation;

What you'll bring

• Bachelor’s Degree or equivalent in related scientific field
• Previous experience in RA (or related discipline) in healthcare industry (better if in medical devices sector) and knowledge of medical devices regulation are preferred
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Good knowledge of English written and spoken

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.