Job Description

Job Description

A Regulatory Affairs Specialist is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime, hybrid role on an initial 12-month contract.

The Regulatory Affairs Specialist will direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

Role of this position

  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

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