EMEA Head of Quality & Regulatory Excellence

WSA – Wonderful Sound for All; Komorniki; On-site; PLN 300,000 - 520,000; Full time

Job summary

WSA – Wonderful Sound for All is seeking a Regional Head of Business Quality to lead regional quality efforts across 15+ countries/entities. You will drive quality strategy, ensure QMS compliance, oversee audits, and coordinate CAPA and regulatory activities to sustain top-tier product quality and regulatory readiness.

The role demands extensive experience in medical devices/regulatory affairs, global quality program delivery, and strong leadership across diverse teams.

Qualifications

• 15+ years of experience in QA and/or regulatory affairs in medical devices or pharmaceuticals.
• Strong experience with Quality Management Systems (ISO 13485, FDA 21 CFR Part 820, EU MDR) and regulatory compliance.
• Experience supporting manufacturing operations, product lifecycle quality, and customer quality processes.
• Proven leadership across international teams and sites.

Responsibilities

• Implement the global quality strategy and develop region-specific quality plans to ensure regulatory compliance and operational performance.
• Foster a strong quality culture across regional operations and leadership teams.
• Partner with executive leadership and cross-functional stakeholders to support strategic initiatives.
• Ensure implementation and maintenance of compliant Quality Management Systems across all regional entities.
• Oversee internal audit programs, regulatory inspections, and external audits (health authorities, customers, notified bodies).
• Ensure effective change control, CAPA, nonconformance management, training, and documentation processes.
• Monitor and review regional quality performance metrics and KPIs, supporting management review activities.
• Provide quality leadership for manufacturing operations, including NPI, manufacturing transfers, and strategic projects.
• Ensure end-to-end quality assurance for production and distribution activities.
• Support root cause investigations and CAPA implementation for operational quality issues.
• Oversee customer-related quality processes, including complaint management and issue escalation.
• Ensure compliance with local regulatory requirements, including facility and product registrations.
• Oversee regulatory inspection readiness and labeling/localization requirements.
• Maintain required licenses and regulatory approvals for marketed products.

Skills

Quality Assurance

Regulatory Affairs

Quality Management Systems

Leadership

Job description

WSA – Wonderful Sound for All is seeking a Regional Head of Business Quality to lead regional quality efforts across 15+ countries/entities. You will drive quality strategy, ensure QMS compliance, oversee audits, and coordinate CAPA and regulatory activities to sustain top-tier product quality and regulatory readiness.

The role demands extensive experience in medical devices/regulatory affairs, global quality program delivery, and strong leadership across diverse teams.