Regulatory Affairs Specialist

5 giorni fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

Vantive, a new company built on Baxter’s legacy, is on a mission to provide best-in-class care to those we serve.

We believe Vantive will not only build leadership in kidney care but also offer meaningful work to those who join us.

As a Regulatory Affairs Specialist at Vantive, you’ll be responsible for the global coordination and preparation of documents/packages for regulatory submissions.

Key Responsibilities:

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

Requirements:

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

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