Regulatory Affairs Specialist with at least 3 years experience in a highly regulated environment such as medical devices required by growing R&D site in Galway city. 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 and notified body interactions.
  • Assist with the preparation of 510(k) regulatory filings and FDA correspondence.
  • Manage regulatory assessment of any device or quality system changes.
  • Ensure country specific registration activities are understood and addressed.
  • Participate in audit preparation.
  • Identify required action to address any regulatory compliance issues.

Requirements:

  • BSc. in Quality/Regulatory or related discipline
  • 3+ years relevant experience in Regulatory Affairs
  • Strong technical writing ability
  • Methodical review approach, and can lead continuous improvement
  • Ability to work within a team environment
  • Understanding of ISO 13485 and FDA QSR quality standards

Please contact Emer Moore to discuss in confidence

00353578638188

emoore@emtechrecruitment.ie 

Refer a Friend