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Regulatory Affairs Analyst

Cpl

Galway, County Galway, Ireland Contract July 11, 2026
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Vacancy Description

Regulatory Affairs Analyst

Summary

The Regulatory Affairs Analyst supports regulatory activities required to obtain and maintain medical device approvals in the US and European markets. This role works closely with cross-functional teams to prepare submissions, maintain regulatory documentation, and support compliance throughout the product lifecycle.

Responsibilities

  • Prepare, compile, submit, track, index, and archive regulatory submissions and supporting documentation for medical devices.
  • Support regulatory submissions including (k), IDE, PMA, HDE, annual reports, technical documentation assessments, design examinations, and change notifications.
  • Maintain regulatory records, technical files, design dossiers, letters to file, and regulatory impact assessments.
  • Assist in responding to regulatory authority questions, deficiency letters, and other agency correspondence.
  • Review product labelling, packaging, a...

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    Vacancy Details

    Location Galway, County Galway
    Country Ireland
    Type Contract
    Category Business Operations Specialists
    Posted July 11, 2026

    About Cpl

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    Cpl

    Galway, Ireland

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