Regulatory Affairs

Exciting new position working as a Regulatory Affairs Specialist to work with a leader in Medical Devices in Longford. This is maternity cover for 12 months to support the Regulatory Affairs Manager with IVDR compliance and post marketing activities.

Overview of the role:

• EU CE Marking: Deliver regulatory activities in line with EU requirements.
• Technical Files: Maintain IVDR (EU 2017/746) compliant documentation.
• Lifecycle & Post-Market: Manage change assessments, surveillance and global registrations.
• Labelling & IFUs: Ensure regulatory compliance of labels, IFUs and marketing content.
• Audits & Inspections: Support internal and external regulatory audits.
• Cross-Functional Collaboration: Partner with key teams to resolve compliance gaps and deliver remediation.

Experience and Education:

• Education: Bachelor's degree in Life Sciences or Engineering.
• Experience: 3+ years in medical device/IVD regulatory affairs.
• Knowledge: EU IVDR, ISO standards, design controls and risk management.
• Skills: Strong communication and prioritisation.

For a confidential discussion and more information on the role contact Courtney Russell

(0)