Regulatory Affairs

Collins McNicholas; Longford; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Collins McNicholas Group is seeking a Regulatory Affairs Specialist for a leading Medical Devices company in Longford, Ireland, on a 12-month maternity cover to support the Regulatory Affairs Manager with IVDR compliance and post-marketing activities.

Key focus areas include EU CE marking, maintaining IVDR documentation, lifecycle and post-market activities, labeling and IFUs, audits, and cross-functional remediation. Strong communication and regulatory knowledge are essential.

Qualifications

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

Responsabilités

• EU CE Marking: Deliver regulatory activities in line with EU requirements.
• Technical Files: Maintain IVDR 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.

Connaissances

Strong communication

Formation

Bachelor’s degree in Life Sciences or Engineering

Description du poste

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
[e-mail]
[phone]