EU Regulatory Affairs Specialist

4 days ago


Dublin, Dublin City, Ireland Sigmar Recruitment Full time
Job Description

The Regulatory Compliance Specialist will be responsible for ensuring that all medical products meet regulatory requirements. This includes maintaining product registrations, acting as EUAR and UKRP, and managing post-market actions.

Key Responsibilities
  • Maintain product registrations in all territories.
  • Act as EUAR and UKRP for partners.
  • Manage post-market actions and NCA communications.
  • Provide advice on new legislation and business needs.
Requirements
  • Educated to degree level or equivalent.
  • Interest in gaining a Regulatory Affairs Certificate (RAC) in medical devices.
  • Good written and verbal communication skills.
  • Quality Management and inspection/auditing experience.


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