Regulatory Affairs Specialist Job In Birr

Regulatory Affairs Specialist sought to lead compliance efforts with global regulations, drive regulatory strategy, and manage audits in a hybrid working environment.

A global healthcare services and products company based in Ireland is seeking an experienced Regulatory Affairs Specialist to lead compliance efforts with global regulations, drive regulatory strategy, and manage audits in a hybrid working environment.

• Ensure compliance with global regulations (e.g., MDR, IVDR, ISO) and manage notified body interactions and regulatory authorities.
• Oversee HPRA inspections, audits, and ensure audit-ready product databases.
• Lead risk management, change control, and regulatory assessments.
• Collaborate with commercial and quality teams to support regulatory submissions and product registrations.
• Monitor and communicate global regulatory changes and their impact.
• Run quality improvement initiatives and manage CAPA processes.
• Lead product and facility inspections, preparation of procedures and instructions including certification assessment and surveillance audits.

Requirements:

• 3 years experience in regulatory affairs within medical devices/healthcare/pharma.
• Strong understanding of ISO, MDD v MDR & CE/UKCA.
• Excellent communication, attention to detail, and problem-solving skills.