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.

• 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.

• 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.

• 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.