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.
- General 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.
Interested in this unique opportunity?
I look forward to receiving your application! Send me a message or comment below for a discreet initial conversation.