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James Cassidy
Life Science

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Details

Quality System & Regulatory Affairs


Reference:JCAO1607 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: R & D Technician, Regulatory Affairs Consultant, Regulatory Affairs Executive

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.
Experience and qualifications The successful candidate will have:
  • 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.
Experience gained within a medical device start-up or smaller, fast-growing company would be advantageous. Lead Auditor certification would also be beneficial.
Personal qualities We are looking for someone who is:
  • 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.
What is on offer
  • 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.
If you are an experienced quality and regulatory professional who enjoys taking ownership in a fast-paced environment, we would be delighted to hear from you.

Apply today or contact us confidentially for further information.