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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Director of Regulatory Affairs


Reference:JCAO0203 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs Director, Regulatory Affairs Manager

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.

The Opportunity Reporting to the executive team, you will take full ownership of regulatory compliance, design assurance, and risk management activities across the organisation.
This role requires strategic oversight combined with a hands-on approach, suited to an experienced regulatory leader who thrives in fast-paced, innovation-driven environments.
Key Responsibilities
  • 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.
About You You are a seasoned regulatory professional with strong leadership capability and a collaborative mindset. You bring both technical depth and the ability to operate strategically at senior level.
Experience & Qualifications
  • 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.
Personal Attributes
  • 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.
Why Apply?
  • 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.
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322