
Head of Medical Device Compliance
4 days ago
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.
- 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.
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