Quality and Regulatory Affairs Manager
About Your New Employer
* Join a dynamic and growing organization with multiple operational sites in Ireland.
* Be part of a team dedicated to excellence in quality and regulatory compliance.
* Work in a collaborative environment that values continuous improvement and professional development.
About Your New Job
Quality Management System (QMS)
* Develop, implement, and maintain an Integrated Management System (IMS) across multiple business units.
* Ensure compliance with ISO 9001, ISO 13485, ISO 27001 certifications, and ISO 17025 accreditation.
* 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.
* 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.
What Skills You Need
* Degree in Science, Quality Management, or related discipline.
* Minimum 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.
What's on Offer
* Competitive salary based on experience.
* Up to 10% bonus.
* Car allowance of €10,000 per year.
* Contributory pension scheme (5%+5%).
* 23 days of holidays.
* Opportunity to work across multiple operational sites in Ireland.