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Regulatory Affairs Maanger

Life Science Recruitment · Galway, County Galway, Ireland

Location
Galway
Job Type
Permanent
Posted
June 17, 2026

Job Description

Regulatory Affairs Manager


Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.


Role/Responsibilities

  • Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle.
  • Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations.
  • Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
  • Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
  • Partner with Quality Assurance to ensure ...

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