Regulatory Affairs Specialist – Galway

Excellent opportunity to join a market-leading medical device company. Reporting to the Section Leader you will ensure that all regulatory responsibilities are carried out efficiently.

Responsibilities:

  • Define regulatory strategy for individual devices within the product development process.
  • Manage CE mark submissions / significant changes and notified body interactions.
  • Assist with the preparation of 510(k) regulatory filings and subsequent FDA correspondence on submissions.
  • Manage regulatoryassessment of any changes.
  • Ensure country specific registration activities are understood.
  • Participate in audit preparation and follow up.
  • Identify and initiate required action to address any adverse trends or regulatory compliance issues.

Requirements:

  • Diploma in a Quality/Regulatory or related discipline
  • 3+ years experience in Regulatory Affairs, medical device preferable.
  • Abilitiy to work independently in a timely manner.
  • Possess strong technical writing ability.
  • Have a methodical review approach.
  • Ability to work within a team environment.
  • Good understanding of ISO 13485 and FDA QSR quality standards.
  • Must be authorised to work in Ireland.

Please contact Mary-Ann Keena to learn more

maryann@emtechrecruitment.ie

+353 (0) 83 0220666

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