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Regulatory Affairs Coordinator

2 weeks ago

County Dublin, Ireland Team Horizon Full time
Why You Should Apply

This is an exciting opportunity to join Team Horizon as a Quality Systems Specialist and contribute to the success of our client, a leading Biotechnology company in Dublin. As a key member of the team, you will be responsible for providing QMS support for combination products across the product lifecycle.

Responsibilities:

  • Support weekly/monthly/quarterly QMS governance reporting
  • Collect and analyze QMS data to support Combination Product Management Review reports, meetings, minutes, and actions
  • Partner with Central Quality Systems and Compliance (CQSC) to deploy a combination product Quality Management System
  • Support cross-functional teams with review board meetings and Supplier Quality Agreement updates
  • Document and periodically review supplier quality requirements and agreements
  • Support Medical Device Quality Team in updating and releasing documents and records in the document management system