Quality System & Regulatory Affairs

Life Science Recruitment; Galway; On-site; EUR 75,000 - 105,000; Full time

Benefits offered by this job

Health insurance

Pension

Flexible working hours

Generous annual leave

Job summary

Life Science Recruitment is supporting an innovative medical device company in Ireland seeking an experienced Quality Systems & Regulatory Manager for a fixed-term maternity cover starting August 2026. You will lead regulatory submissions, maintain QMS, and drive compliance across the product lifecycle.

Collaborating with cross-functional teams, you will ensure products meet quality and regulatory requirements, manage CAPAs, and liaise with authorities to support development and launches of

Qualifications

• 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.
• Subject-matter expert with leadership abilities.
• Strong communication, organisational and project-planning skills.
• Ability to work independently while collaborating with cross-functional teams.
• Fluency in written and spoken English.
• Experience in start-up or fast-growing medical device companies is advantageous.
• Lead Auditor certification would be beneficial.

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.

Skills

Quality management

Regulatory submissions

FDA knowledge

ISO standards

Leadership

Education

Level 8 degree in engineering/science/STEM/quality

Job description

Job Description

Location: IrelandContract: Fixed-term maternity coverStart date: August 2026Sector: 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

• 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

• 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.