Job Title: Director of Regulatory Affairs
The company is an ambitious medical device start-up based in Galway, entering a critical phase of operational expansion.
About Us:
We are backed by a proven management team with a strong track record in the start-up sector.
Key Responsibilities:
* Develop global regulatory strategies to support product development and market expansion activities.
* Manage all regulatory submissions and ensure alignment with commercial timelines.
* Serve as primary liaison with regulatory authorities, representing the company in regulatory interactions and negotiations.
* Build and lead a high-performing regulatory team to support product development and market access activities.
* Monitor evolving regulatory requirements to ensure proactive compliance across geographies.
* Collaborate with cross-functional teams 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 10 years' experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role.
* Proven success in preparing regulatory submissions for Class II/III devices.
* Strong understanding of the global regulatory environment, including emerging markets.
* Ability to think strategically while executing detailed plans.
* Exceptional leadership, communication, and stakeholder management skills.
* Comfortable operating in a fast-paced entrepreneurial environment.
* Degree in Life Sciences, Engineering, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.