**Director of Regulatory Affairs Medical Device Start-Up Galway**
About the Company:
Our client is an ambitious 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 key role 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:
A 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).
A strong understanding of the global regulatory environment, including emerging markets.
The 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.
A 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.