A leadership role with real impact

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.

The role

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.

Your team

You will lead a team of seven professionals based at our production site in Anderstorp, with four direct reports:

• Quality Leader, Operations & Supplier Quality Assurance

• Laboratory Manager, Test Center

• Two Regulatory Affairs Specialists

Your key responsibilities

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

• Ensure product compliance and quality readiness before market release.

• Verify that technical documentation fulfills applicable regulatory and quality requirements.

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

• Maintain, develop and continuously improve certified quality and environmental management systems.

• Participate in management reviews and report on quality system performance, compliance status and improvement opportunities.

• Lead investigations, corrective actions and preventive actions related to complaints, deviations and non-conformities.

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

• Manage supplier quality activities, including supplier complaints, evaluations and quality performance follow-up.

• Represent Etac in interactions with certification agencies, regulatory authorities and external auditors.

• 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.

Your profile

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.

We believe you bring:

• Solid experience working with medical device regulations, quality management systems and regulatory compliance.

• Strong knowledge of ISO 13485, ISO 14001, MDR, risk management and quality improvement methodologies.

• Proven leadership experience, including leading teams, projects or organizational improvement initiatives.

• Experience interacting with auditors and regulatory authorities is an advantage.

• A university degree in engineering or another relevant scientific discipline, or equivalent experience meeting the qualification requirements for PRRC under MDR.

• Knowledge of environmental management systems and Lean Production/Lean Management principles.

• Professional proficiency in English. Swedish and additional languages are considered an advantage.

Why Etac

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.

Interested?

If you would like to learn more about the position, please contact Lars-Erik Gårdeskorg at lars-erik.gardeskog@etac.com