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.

Summary 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


#J-18808-Ljbffr