Regulatory Affairs Specialist - 12-Month IVDR Focus

Collins McNicholas Group; Longford; On-site; EUR 55,000 - 75,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Strong communication

Education

Bachelor’s degree in Life Sciences or Engineering

Job description

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.