Director Of Global Regulatory Strategy

13 hours ago

Galway, Galway, Ireland beBeeRegulatory Full time €150,000 - €200,000

Seeking an accomplished Regulatory Affairs leader to spearhead the development and execution of a global regulatory strategy for medical devices. This pivotal role involves driving product approvals, ensuring market access, and collaborating with cross-functional teams to integrate regulatory requirements into project plans.

">Key Responsibilities:
  • 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.

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 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 key architect of the company's regulatory success during an exciting growth phase.
  • A senior leadership role with real influence across the business.
  • A competitive salary, equity participation, and 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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