Head of Quality Assurance and Regulatory AffairsMedical Device ManufacturerThis is a hands on leadership role for someone who has already led MDR work and wants full ownership of Quality and Regulatory.A medical device manufacturer in Tullamore is appointing a Head of Quality Assurance and Regulatory to lead the QA and Regulatory function and take the site through MDR compliance. You will have direct access to the decision makers and the authority to implement change.This role suits someone who wants responsibility, visibility and the chance to build systems properly rather than maintain what already exists.What you will do:Lead Quality Assurance and Regulatory end to endOwn and evolve the Quality Management SystemLead EU MDR implementation and ongoing complianceAct as Person Responsible for Regulatory Compliance under Article 15Manage notified body relationships and regulatory submissionsLead audits, CAPA, risk management and continuous improvementBuild, develop and mentor the QA and Regulatory teamWhat we are looking for:Strong experience within medical device manufacturingProven experience leading EU MDR implementationExpert working knowledge of ISO standards and regulatory frameworksCredibility to operate as PRRCConfident leadership style that works on the floor as well as at senior levelWhat is on offer:Excellent base salary with a competitive benefits packageRelocation package if requiredDirect influence over how quality and regulatory is run on siteA role with a clear runway, where you can make your mark over the next 12 to 24 monthsLong term career opportunity within a growing manufacturerInterested:If you are open to a confidential discussion, apply via Indeed and you will be contacted directly. All applications will be treated in strict confidence.Job Types: Full-time, PermanentPay: From €1,000.00 per yearBenefits:Company pensionEmployee discountFlexitimeOn-site parkingPrivate medical insuranceRelocation assistanceWork Location: In person