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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Quality and Regulatory Affairs Manager


Reference:JCAO0806 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Manager, Regulatory Affairs Manager

Quality & Regulatory Affairs Manager Location: Dublin, Ireland (Hybrid)
Type: Full-Time
About the Opportunity An innovative and rapidly growing medical device company is seeking an experienced Quality & Regulatory Affairs Manager to lead quality and regulatory activities as the organisation progresses through post-market clinical activities and prepares for commercial expansion in the United States and Europe.
This is an exciting opportunity to join a high-growth MedTech business that has achieved FDA clearance for its first technology indication and is entering a pivotal phase of development. The successful candidate will play a key role in maintaining regulatory compliance, leading the Quality Management System, supporting commercial launch activities, and shaping the future quality and regulatory strategy of the organisation.
This position offers a blend of strategic leadership and hands-on execution within a dynamic, fast-paced environment.
Key Responsibilities

  • Lead all quality and regulatory activities supporting post-market clinical programmes in the United States.
  • Drive quality and regulatory readiness for U.S. commercial launch activities.
  • Own, maintain, and continuously improve the Quality Management System (QMS).
  • Act as the Quality Management Representative.
  • Ensure compliance with FDA regulations, Quality System Regulations, ISO 13485, and other applicable standards.
  • Oversee design control activities throughout the product lifecycle.
  • Manage complaint handling, CAPA processes, post-market surveillance, and vigilance activities.
  • Support commercial launch readiness, including labelling, distribution controls, and traceability requirements.
  • Provide quality oversight for manufacturing scale-up and technology transfer activities.
  • Lead change control processes and regulatory impact assessments.
  • Manage supplier quality programmes, internal audits, and inspection readiness activities.
  • Maintain risk management documentation and post-market risk assessments.
  • Collaborate across engineering, manufacturing, clinical, and commercial teams to ensure compliance and quality excellence.
  • Build, mentor, and develop a high-performing Quality & Regulatory team.
  • Lead future regulatory submissions, including CE Mark activities.
  • Serve as the primary contact for regulatory authorities, notified bodies, auditors, and external partners.
Candidate Profile Essential Requirements
  • Bachelor's degree in Engineering, Life Sciences, or a related discipline.
  • Minimum of 8 years' experience in Quality and Regulatory Affairs within the medical device industry.
  • Strong experience supporting FDA-cleared medical devices and post-market commercial activities.
  • Experience managing or owning a Quality Management System.
  • In-depth knowledge of FDA QMSR (21 CFR Part 820) and ISO 13485 requirements.
  • Experience with medical device Design Control processes.
  • Experience supporting post-market clinical studies.
  • Knowledge of sterility and sterilisation requirements for medical devices.
  • Previous experience acting as a Management Representative or equivalent quality leadership role.
  • Strong risk management, problem-solving, and decision-making skills.
  • Ability to thrive in a fast-paced, hands-on environment with evolving priorities.
  • Excellent communication and stakeholder management skills.
Desirable Experience
  • Experience supporting CE Mark submissions and European regulatory requirements.
  • FDA inspection preparation and audit experience.
  • Lead Auditor or Internal Auditor certification.
  • Previous experience working within a start-up or early-stage medical device company.
What's on Offer
  • Hybrid working model with flexible working arrangements.
  • Opportunity to play a key role in bringing innovative medical technology to patients worldwide.
  • Significant exposure to commercial launch activities and international regulatory strategy.
  • Career progression opportunities within a growing organisation.
  • Collaborative, entrepreneurial, and mission-driven culture.
  • Travel opportunities and interaction with global medical device industry leaders.
  • Competitive salary and comprehensive benefits package.
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322