Quality Systems & Regulatory Manager – Maternity Cover Location: Ireland
Contract: Fixed-term maternity cover
Start date: August 2026
Sector: Medical Devices
The opportunity We are working with an innovative, rapidly growing medical device company developing patient-focused technologies designed to improve quality of life
The company is seeking an experienced Quality Systems & Regulatory Manager to join its team on a fixed-term maternity cover contract commencing in August 2026.
This is a broad, hands-on role supporting an expanding portfolio of medical devices across quality systems, regulatory submissions, new product introduction and ongoing compliance. You will work closely with cross-functional teams and external regulatory stakeholders, helping to bring safe, effective and life-changing products to patients.
The position would particularly suit someone who enjoys the pace and responsibility of a start-up or growing medical device business.
Key responsibilities

• Support new quality initiatives, improvement projects and new product introductions.
• Ensure products and processes meet applicable quality and regulatory requirements.
• Lead corrective and preventive actions relating to product and quality-system deficiencies.
• Identify quality issues and recommend practical, compliant solutions.
• Work with departments across the business to ensure quality-system requirements are understood and followed.
• Provide management with clear reports and updates on quality and regulatory matters.
• Lead assigned projects and coordinate with internal and external stakeholders to achieve agreed outcomes.
• Challenge existing practices constructively and promote continuous improvement.
• Assess product, process and manufacturing changes for regulatory implications.
• Ensure continued compliance with relevant regulatory approvals.
• Lead the preparation, compilation and submission of regulatory applications.
• Coordinate regulatory inputs throughout the product-development lifecycle.
• Develop regulatory strategies and advise teams on submission pathways, testing requirements and approval considerations.
• Provide technical guidance, regulatory training and mentoring to cross-functional colleagues.
• Manage materials required for regulatory submissions, licence renewals and annual registrations.
• Liaise with regulatory authorities, notified bodies and device reviewers regarding submissions and regulatory strategies.
• Review labelling, manufacturing information, marketing materials and clinical documentation for regulatory compliance.
• Maintain audit readiness and provide regulatory information to Quality Assurance, notified bodies, competent authorities and the FDA.
• Research regulatory approvals and pathways for comparable products and communicate relevant findings to stakeholders.

• A Level 8 degree or equivalent qualification in engineering, science, STEM, quality or another relevant discipline.
• At least seven years’ relevant experience within the medical device or healthcare sector.
• Excellent knowledge of medical device quality-management system requirements.
• Strong working knowledge of FDA requirements and applicable ISO standards.
• Experience preparing or supporting medical device regulatory submissions.
• The ability to operate as a subject-matter expert and provide leadership within their area.
• Strong communication, organisational and project-planning skills.
• The ability to work independently while collaborating effectively with cross-functional teams.
• Strong initiative, sound judgement and the ability to manage competing priorities.
• Fluency in written and spoken English.

• A creative and pragmatic problem-solver.
• Comfortable taking ownership and working with urgency.
• Organised and able to deliver projects within agreed timelines.
• An open and proactive team player.
• Confident providing and receiving constructive feedback.
• An effective communicator who can explain quality and regulatory requirements clearly.
• Motivated by the opportunity to contribute to products with a meaningful patient impact.

• A competitive salary aligned with the medical device sector.
• A flexible benefits package, including health insurance and pension.
• Flexible working hours.
• A generous annual leave policy.
• The opportunity to influence the development of multiple patient-facing medical devices.
• First-hand experience of working within a high-growth, innovative medical device company.