Visionary Leader in Global Regulatory Affairs

9 hours ago

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

Regulatory Affairs Leadership Role

We are seeking an experienced regulatory affairs professional to lead our global regulatory strategy, ensuring successful product approvals and market access.

Key Responsibilities:

  • Develop and drive regulatory strategies to support product development, commercialization, and market expansion activities.
  • Manage all regulatory submissions and ensure alignment with commercial and operational timelines.
  • 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.

What We Offer:

  • A senior leadership role with real influence across the business.
  • Competitive compensation package and equity participation.
  • Opportunity to be a key architect of our company's regulatory success during an exciting growth phase.
  • High-energy culture with a leadership team known for successful start-up growth and exits.

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