Director of Regulatory Affairs

Director of Regulatory Affairs – Medical Device Start-Up – Galway

About the Company
Our client is an ambitious, well-funded medical device start-up based in Galway, entering a critical phase of operational expansion. Backed by a proven management team with a strong track record in the start-up sector, the company is primed for significant growth both domestically and internationally.

The Opportunity
We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join the executive team. This is a key role where you will define and lead the company's global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly.

Key Responsibilities

• Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities.
• Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines.
• Serve as the primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations.
• Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities.
• Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies.
• Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making.
• Support due diligence and partnership activities through regulatory assessments and strategy development.

Director of Regulatory Affairs – Medical Device Start-Up – Galway

About the Company
Our client is an ambitious, well-funded medical device start-up based in Galway, entering a critical phase of operational expansion. Backed by a proven management team with a strong track record in the start-up sector, the company is primed for significant growth both domestically and internationally.

The Opportunity
We are seeking a Director of Regulatory Affairs with a strong strategic vision and leadership capability to join the executive team. This is a key role where you will define and lead the company's global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly.

Key Responsibilities

• Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities.
• Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines.
• Serve as the primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations.
• Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities.
• Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies.
• Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making.
• Support due diligence and partnership activities through regulatory assessments and strategy development.

About You

• Minimum of 10 years' experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role.
• Proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways essential).
• Strong understanding of the global regulatory environment, including emerging markets.
• Ability to think strategically while executing detailed regulatory plans.
• Exceptional leadership, communication, and stakeholder management skills.
• Comfortable operating in a fast-paced, high-growth, entrepreneurial environment.
• Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.

What's on Offer

• The chance to be a key architect of the company's regulatory success during an exciting growth phase.
• A senior leadership role with real influence across the business.
• Competitive salary, equity participation, and an attractive benefits package.
• An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits.

If interested in discussing further please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086 0204322
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