Regulatory Affairs Specialist

7 ore fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

Baxter is revolutionizing kidney care and other vital organ support. As a Regulatory Affairs Specialist, you will play a crucial role in the global coordination of regulatory submissions.

Job Summary

This role involves supporting the execution of regulatory project plans, maintaining awareness of regulatory requirements, and ensuring continued learning. You will also be responsible for maintaining regulatory files in a format consistent with requirements, participating as an active team member of project teams, and compiling responses to questions from regulatory authorities.

Key Responsibilities
  • Supports regulatory project plan execution;
  • Maintains awareness of regulatory requirements and ensures continued learning;
  • Maintains regulatory files in a format consistent with requirements;
  • Participates as an active team member of project teams as required;
  • Compiles and prepares responses to questions from regulatory authorities according to plan;
  • Edits and proofreads regulatory documentation;
  • Assists in preparation and review of labeling, SOP's, and other departmental documents;
  • Compiles under supervision regulatory documents for submission;
  • Tracks status and progress of regulatory documentation;
Requirements
  • 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;
Estimated Salary Range: $60,000 - $80,000 per annumAbout Vantive

Vantive will build on Baxter's nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to people worldwide. We believe Vantive will not only build our leadership in the kidney care space but also offer meaningful work to those who join us.

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