A global healthcare services and products company based in County Offaly is seeking an experienced Regulatory Affairs Specialist to join their team. The successful person will lead compliance efforts with global regulations such as MDR, IVDR, and ISO standards. This role offers the opportunity to drive regulatory strategy, manage audits, and collaborate cross-functionally to ensure seamless compliance. This is a full-time permanent position offering hybrid working.
Key Responsibilities:
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, HPRA, WHO inspections, other regulatory inspections and supplier 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.
For a confidential discussion about this opportunity please contact Ranait Coughlan
ranait.coughlan@collinsmcnicholas.ie
(090) 6450664 (01) 66 200 88