Regulatory Affairs Leader

6 days ago

Galway City, Ireland beBeeRegulatory Full time €120,000 - €140,000
Director of Regulatory Affairs

We are seeking an experienced Director to lead our global regulatory strategy, ensuring successful approvals and market access as we scale rapidly.

  • This role offers a unique opportunity to be a key architect of our regulatory success during an exciting growth phase.

You will define and drive global regulatory strategies to support product development, commercialization, and market expansion activities.

  1. Develop and drive global regulatory strategies to support product development, commercialization, and market expansion activities.
  2. Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines.
  3. Serve as the primary liaison with regulatory authorities, representing us in all regulatory interactions and negotiations.
  4. Build and lead a high-performing regulatory team to support both early-stage product development and later-stage market access activities.
  5. Monitor and interpret evolving regulatory requirements to ensure proactive compliance across multiple geographies.
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.
  • A comfort level operating in a fast-paced, high-growth, entrepreneurial environment.
What's on Offer
  • The chance to be a key architect of our regulatory success during an exciting growth phase.
  • A senior leadership role with real influence across the business.
  • An attractive benefits package.
  • An entrepreneurial, high-energy culture with a leadership team known for successful start-up growth and exits.

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