Quality & Regulatory Affairs Manager (PRRC)

At Etac, we develop solutions that help people live more independent lives. We are now looking for a Quality & Regulatory Affairs

Manager (PRRC) to lead our Quality, Testing and Regulatory Affairs function and play a key role in ensuring the highest standards

of quality, safety, and regulatory compliance.

Leading a team of seven quality, testing and regulatory professionals, you will combine strategic leadership with hands-on

expertise in a role that directly influences product quality, regulatory compliance, operational excellence and customer trust.

As Quality & Regulatory Affairs Manager (PRRC), you will own Etac Supply Center's quality and regulatory compliance framework

while leading and developing the local Quality, Testing and Regulatory Affairs function.

This is a broad leadership role combining strategic responsibility, operational excellence, people leadership and cross-functional

collaboration. You will guide quality initiatives, support regulatory compliance, and drive continuous improvement efforts,

ensuring that products, processes and systems meet Etac's high standards for quality, compliance, cost efficiency and user safety.

You will act as the company's appointed Person Responsible for Regulatory Compliance (PRRC) in accordance with MDR Article 15 and

serve as management's representative for the quality management system.

The role reports to the SVP Mobility Europe & RoW. You will work closely with the Site Manager and play a key role in the local

leadership team, partnering with stakeholders across Operations, R&D, Supply Chain, Purchasing and Product Management.

• Lead and develop the Quality, Testing and Regulatory Affairs function, building a high-performing and collaborative team

culture.

• Act as PRRC and ensure compliance with MDR requirements, including vigilance, post-market surveillance and regulatory reporting

obligations.

• Drive process improvements that increase efficiency and reduce quality-related costs through Lean principles and structured

improvement methodologies.

• Work closely with Operations, R&D, Supply Chain, Purchasing and external regulatory stakeholders to ensure consistent quality

performance throughout the value chain.

• Translate regulatory requirements into practical and sustainable business solutions that support both compliance and business

objectives.

You combine regulatory expertise with a practical and business-oriented approach to quality management. You are comfortable making

decisions in situations where compliance requirements, business priorities and operational realities need to be balanced.

You build trust through credibility, sound judgment and strong communication skills. You enjoy developing people, leading change

and helping organizations improve rather than simply enforcing rules.

You are analytical, improvement-oriented and able to translate complex regulatory requirements into pragmatic actions that create

value. Equally important, you thrive when collaborating across functions and influencing stakeholders at all levels of the

organization.

• A university degree in engineering or another relevant scientific discipline, or equivalent experience meeting the

qualification requirements for PRRC under MDR.

At Etac, you'll join a purpose-driven organization where innovation, quality and sustainability help improve people's lives every

day. This is an opportunity to take on a visible leadership role, develop a skilled team, and help shape the future of Quality &

Regulatory Affairs in a growing international medical device business.