Our client is a neurovascular company based in Galway, Ireland, developing a next-generation catheter-based platform to transform the treatment of acute ischemic stroke. With regulatory approvals secured, promising clinical data, and commercialisation now underway, they are entering a new phase of growth and global expansion. They are currently hiring a Senior Director of Regulatory Affairs to take a key strategic leadership role in shaping their global regulatory strategy.

The role

As Senior Director of Regulatory Affairs, you will be responsible for leading and executing the global regulatory roadmap across key markets, including the US and Europe. Reporting directly to executive leadership, you will oversee critical regulatory submissions (including 510(k) and CE Mark), act as PRRC under MDR, and work cross-functionally with internal teams to ensure design assurance and risk management processes align with global requirements. You will also serve as the primary point of contact for regulatory bodies such as the FDA and Notified Bodies.

Key responsibilities

• Define and execute global regulatory strategies in alignment with company goals.
• Lead regulatory submissions including 510(k), CE Mark, and other global filings.
• Act as Person Responsible for Regulatory Compliance (PRRC) under EU MDR.
• Maintain direct communication with regulatory authorities including the FDA and Notified Bodies.
• Provide strategic input to design assurance and risk management activities.
• Stay informed of evolving global regulatory landscapes and guide internal teams accordingly.
• Collaborate with cross-functional teams including R&D, Quality, and Clinical to ensure aligned execution.
• Represent the company in regulatory audits and inspections.
• Support market entry and expansion activities from a regulatory perspective.
• Mentor and grow internal regulatory capabilities as the company scales.

Required experience and qualifications

• 15+ years of experience in the medical device industry, ideally with Class II/III products.
• At least 7 years in a senior or leadership regulatory role.
• Proven success in leading international regulatory submissions in a start-up or scale-up environment.
• Strong knowledge of US FDA and EU MDR regulatory frameworks.
• Excellent leadership and communication skills, with a collaborative and hands-on approach.
• A strategic thinker with the ability to operate effectively in a dynamic and fast-paced setting.

Benefits

• Be part of a company at the forefront of innovation in stroke intervention.
• Work in a purpose-driven environment with a talented and passionate team.
• Opportunity to lead global regulatory strategy during a critical growth phase.
• Competitive compensation package.

Your consultant

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in Quality and Regulatory Affairs recruitment across the MedTech and pharmaceutical sectors in Europe. Taylor works closely with high-growth companies to identify and engage experienced professionals who can drive compliance, innovation, and operational excellence. With a deep understanding of the regulatory landscape and industry demands, Taylor focuses on building long-term partnerships that deliver real impact.