Director/PRRC QA/RA and compliance

Ekwa Consult; Vlaanderen; Sur place; EUR 180 000 - 280 000; Plein temps

Résumé du poste

Ekwa Consult is seeking a visionary leader to architect the global QA/RA and act as the Group PRRC for a high-growth MedTech organization. This executive role carries formal regulatory responsibility across the group, ensuring patient safety and compliance.

Reporting to the CEO, you will translate EU MDR, FDA QMSR, and related standards into a competitive advantage while guiding a global footprint of facilities. This is a strategic, leadership-driven opportunity with a bold growth trajectory.

Qualifications

• 10+ years of QA/RA experience in MedTech.
• Proven leadership in global regulatory compliance.
• Deep knowledge of EU MDR and FDA QMSR.
• Strategic thinker with cross-functional influence.

Responsabilités

• Define and lead the global QA/RA strategy for the group.
• Ensure MDR compliance across all facilities.
• Directly report to the CEO and drive regulatory initiatives.
• Oversee risk management, cybersecurity, and SaMD considerations.

Connaissances

QA/RA leadership

Regulatory affairs

MedTech

Executive leadership

Strategy

Description du poste

Visionary Director QA/RA & Group PRRC for Global MedTech Leader

Ekwa Consult is seeking a strategic leader to architect the future of quality and compliance for a high-growth international player in critical medical systems.

This is more than an executive role; you will be the formal Person Responsible for Regulatory Compliance (PRRC) for the group.

Why this role is a game-changer:

• Legal Accountability: As the group's PRRC, you hold formal authority and independence under the MDR, serving as the ultimate guardian of patient safety.
• Direct Strategic Impact: Reporting directly to the CEO, you translate complex regulations (EU MDR, FDA QMSR) into a competitive advantage.
• Global Headquarters: Based in Belgium (Lummen area), you will oversee a global footprint of 12 production facilities across the US, Europe, and Asia.
• Exponential Growth: Be a key driver in an ambitious 'buy-and-build' strategy aiming to double revenue to €200M+.
• Innovation Leadership: Navigate the latest frontiers, including the EU AI Act, SaMD, and cybersecurity requirements.

We are looking for a heavyweight with 10+ years of QA/RA experience in MedTech and a proven track record in leadership.