Director of Regulatory Affairs 📍 Galway, Ireland (Hybrid)
Lead Regulatory Strategy in a High-Growth MedTech Environment An innovative, growth-stage medical device company based in Galway is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy and compliance activities.
This is a senior leadership opportunity within a dynamic SME environment, offering the chance to shape regulatory direction while partnering closely with executive leadership and cross-functional teams.

• Act as Person Responsible for Regulatory Compliance (PRRC) under EU MDR (2017/745).
• Define and execute global regulatory strategy for new product development and lifecycle management.
• Lead all regulatory submissions including FDA 510(k) and CE Mark applications.
• Manage regulatory authority interactions (FDA, Notified Body, Competent Authorities).
• Oversee design assurance and risk management processes.
• Ensure compliance with post-market surveillance and vigilance requirements (EU & US).
• Lead regulatory review of promotional and advertising materials.
• Direct regulatory strategy related to field actions or recalls if required.
• Build, mentor, and develop regulatory and design assurance capability.
• Provide strategic regulatory guidance at executive level.

• Degree in Engineering, Science, or health-related discipline.
• 15+ years’ experience within the medical device industry.
• Minimum 7 years in a senior leadership role.
• Deep understanding of EU MDR and US FDA regulatory pathways.
• Proven experience leading 510(k) and CE Mark submissions.
• Strong background in design control and risk management.
• Experience working within an SME or high-growth MedTech environment is highly desirable.

• Strategic thinker with a pragmatic, hands-on approach.
• Highly organised with strong prioritisation capability.
• Comfortable managing complexity in a growing organisation.
• Strong interpersonal and communication skills.
• Proven ability to lead, coach, and develop teams.

• Senior leadership role with significant influence.
• Opportunity to shape regulatory strategy within an innovative organisation.
• Collaborative and inclusive working environment.
• Competitive package aligned with experience.