Global Head of Quality & Regulatory Strategy

Hero Recruitment Group; Limerick; On-site; EUR 120,000 - 180,000; Full time

Job summary

Hero Recruitment Group is recruiting for a Director of Quality & Regulatory Affairs in Mid-West Ireland. This senior role leads QA, QC and Regulatory Affairs across Ireland and international sites, reporting to the CEO and contributing to the Senior Leadership Team.

The role requires a degree in Science or Engineering, 12+ years in Quality/Regulatory, and hands-on IVDR with Notified Body experience. It offers strategic influence and hands-on leadership in a growing diagnostics company.

Qualifications

• Degree in Science, Engineering or a related discipline.
• 12+ years in Quality and/or Regulatory within medical devices or IVD.
• Hands-on IVDR experience and Notified Body/FDA inspections.

Responsibilities

• Own and lead the ISO 13485 QMS across sites, including IVDR, FDA 21 CFR Part 820 and MDSAP.
• Act as Management Representative and drive quality objectives and KPIs.
• Lead Notified Body, FDA, HPRA, MHRA and customer audits from prep to closure.
• Oversee CAPA, nonconformance, complaints, internal audits, supplier quality, change control and document control.
• Ensure product release, QC testing and batch review meet regulatory and customer requirements.
• Build a practical, risk-based quality culture across manufacturing, R&D and commercial teams.
• Set and deliver global regulatory strategy for portfolio and pipeline.
• Own IVDR technical documentation and Notified Body relationships.
• Lead FDA submissions and MHRA/UKCA registrations, plus other export markets.
• Monitor regulatory change and translate into action plans.

Skills

Leadership

Regulatory strategy

Quality management

Audits (Notified Body/FDA)

Cross-functional collaboration

Risk management

Education

Science/Engineering degree

Job description

Hero Recruitment Group is recruiting for a Director of Quality & Regulatory Affairs in Mid-West Ireland. This senior role leads QA, QC and Regulatory Affairs across Ireland and international sites, reporting to the CEO and contributing to the Senior Leadership Team.

The role requires a degree in Science or Engineering, 12+ years in Quality/Regulatory, and hands-on IVDR with Notified Body experience. It offers strategic influence and hands-on leadership in a growing diagnostics company.