Strategic Regulatory Affairs Leader

2 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €120,000 - €150,000

Strategic Regulatory Affairs Leader


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.

  • 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.

Requirements

  • 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 part of a senior leadership team driving significant growth and innovation.
  • A highly competitive salary, equity participation, and an attractive benefits package.
  • An opportunity to work in a dynamic, entrepreneurial culture with a strong track record of start-up growth and exits.

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