Executive Director of Global Regulatory Strategy

1 week ago

Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €100,000 - €140,000
Global Regulatory Affairs Leadership Opportunity

About the Position:

We are seeking a highly experienced Director of Regulatory Affairs to join our executive team. This key role involves defining and leading our global regulatory strategy, ensuring successful approvals and market access as our business scales rapidly.

Key Responsibilities:

  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 the company 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.
  6. Collaborate closely with cross-functional teams including R&D, Quality, Clinical, and Commercial to integrate regulatory requirements into project plans and strategic decision-making.
  7. Support due diligence and partnership activities through regulatory assessments and strategy development.

Requirements:

This role requires a minimum of 10 years' experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership position. Strong understanding of the global regulatory environment, including emerging markets, is essential. The ideal candidate will have proven success in preparing and leading regulatory submissions for Class II/III devices (EU MDR and FDA pathways required).

What We Offer:

A dynamic and fast-paced work environment, opportunities for professional growth and development, and a competitive compensation package make this a compelling opportunity for experienced professionals in Regulatory Affairs.

Preferred Qualifications:

  • Degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field; Regulatory Affairs Certification (RAC) is advantageous.

  • Director Of Quality/Regulatory

    2 weeks ago

    Galway, Galway, Ireland Hobson Prior Full time

    Are you a strategic thinker who is experienced in Quality Assurance and Regulatory Affairs?This Director position could be your next best moveHobson Prior is searching on behalf of our client who are seeking an experienced and strategic Director of QA/RA to lead their Quality Assurance and Regulatory Affairs functions.This role is critical in ensuring their...

  • Director of Quality/Regulatory

    4 days ago

    Galway, Galway, Ireland Hobson Prior Full time

    Are you a strategic thinker who is experienced in Quality Assurance and Regulatory Affairs? This Director position could be your next best moveHobson Prior is searching on behalf of our client who are seeking an experienced and strategic Director of QA/RA to lead their Quality Assurance and Regulatory Affairs functions. This role is critical in ensuring...

  • Strategic Regulatory Leader

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €120,000

    Director of Regulatory AffairsWe are seeking a senior professional to lead our regulatory affairs team and drive global strategies for product development, commercialization, and market expansion.About the RoleDevelop and execute regulatory strategies to support business growth and ensure compliance with international regulations.Manage all regulatory...

  • Director, Global Quality

    4 days ago

    Galway, Galway, Ireland Celestica Full time

    OverviewJob location: Ireland, Galway. Reports to Celestica's Vice President of Global Quality. The Director, Global Quality for HealthTech is responsible for the global HealthTech quality team to establish and maintain a quality-first culture across worldwide manufacturing facilities, collaborating with customers, suppliers, and partners, and ensuring...

  • Strategic Regulatory Affairs Director

    1 day ago

    Galway, Galway, Ireland beBeeRegulatory Full time €120,000 - €140,000

    Global Regulatory Strategy LeaderWe are seeking an accomplished leader to drive the company's global regulatory strategy. The ideal candidate will have a strong strategic vision, leadership capability, and experience in preparing and leading regulatory submissions for Class II/III devices.About You:A minimum of 10 years' experience in Regulatory Affairs...

  • Chief Regulatory Compliance Officer

    1 week ago

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

    Director of Regulatory Affairs Job DescriptionThe successful candidate 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...

  • Medical Device Regulatory Compliance Manager

    4 days ago

    Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €90,000 - €120,000

    Regulatory Affairs DirectorThe Regulatory Affairs Director will play a pivotal role in leading and overseeing all regulatory compliance activities for a fast-growing medical device company based in the West of Ireland. This leadership position will define and execute regulatory strategies in support of new product development and post-market activities.Key...

  • Affairs Leader for Global Market Expansion

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €120,000

    Job Title: Regulatory Affairs DirectorThis is a key leadership role where you will define and lead the company's global regulatory strategy, ensuring successful approvals and market access as the business scales rapidly.Key Responsibilities:Develop and drive global regulatory strategies to support product development, commercialization, and market...

  • Visionary Leader in Global Regulatory Affairs

    8 hours ago

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

    Regulatory Affairs Leadership RoleWe 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...

  • Director of Quality Assurance

    3 days ago

    Galway, Galway, Ireland SciPro Full time

    OverviewAre you passionate about driving excellence in quality systems and regulatory compliance? This senior leadership role offers the opportunity to oversee and shape global quality and regulatory operations for an organization developing innovative medical technologies.Director of Quality & Regulatory AffairsAs Director of Quality & Regulatory Affairs,...