Role Title:
Quality and Regulatory Affairs Manager
Role Type:
Permanent
Location:
Naas, Co. Kildare
We are currently recruiting a Quality and Regulatory Affairs Manager for a Medical Device distributer based in Naas, Co. Kildare. This position will lead all Quality and Regulatory activities ensuring compliance with international standards, regulatory requirements, and health and safety legislation, while driving continuous improvement across supply chain and distribution processes.
Key Duties and Responsibilities
Quality Management System (QMS)
Develop, implement, and maintain the Integrated Management System (IMS).
Ensure compliance with ISO 9001, ISO 13485, ISO 27001 certifications and ISO 17025 accreditation.
Integrate QMS processes across sites to streamline operations and maintain consistency.
Conduct internal audits and coordinate external audits, ensuring timely closure of findings.
Manage corrective and preventive actions (CAPAs) and lead CAPA teams.
Oversee document control and change control processes.
Validate new equipment and materials, including training and monitoring.
Regulatory Affairs
Ensure compliance with MDR/IVDR, GDP guidelines, and applicable health regulations.
Manage product registration and regulatory submissions via EUDAMED and MHRA.
Monitor regulatory changes and update internal policies accordingly.
Act as primary liaison with regulatory authorities and notified bodies.
Prepare and maintain technical documentation for regulatory compliance.
Health & Safety
Act as Safety Officer, ensuring compliance with company Safety Statement and Risk Assessments.
Help provide health and safety training with external consultants and ensure protective equipment is available.
Monitor workplace safety and implement risk mitigation measures.
Supplier & Customer Quality
Manage supplier onboarding, qualification, and performance monitoring.
Ensure supplier compliance with quality standards and resolve quality issues promptly.
Review product specifications and disposition decisions (acceptance/rejection).
Build strong relationships with customers on quality and regulatory matters.
Information Security
Implement and maintain ISO 27001 standards for information security.
Ensure confidentiality, integrity, and availability of information assets.
Leadership & Continuous Improvement
Lead and develop the Quality & Regulatory team, providing coaching and feedback.
Drive continuous improvement initiatives across quality and compliance processes.
Monitor KPIs and report progress to senior management.
Support implementation of new systems (e.g., ERP) to enhance compliance and efficiency.
Qualifications & Experience
Degree in Science, Quality Management, or related discipline.
5+ years' experience in Quality Assurance and Regulatory Affairs within healthcare, medical devices, or pharmaceutical sectors.
Strong knowledge of ISO standards, MDR/IVDR, and GDP guidelines.
Proven experience in audits, CAPA management, and risk assessment.
Excellent leadership, communication, and stakeholder management skills.
Key Competencies
Strategic thinking and problem-solving.
Strong organisational and project management skills.
Ability to influence and drive a quality-focused culture.
Attention to detail and commitment to compliance.
Progressive minded, resilient and flexible