PRRC & Quality Lead — MDR Compliance Architect

Etac Group; Anderstorp; On-site; SEK 900,000 - 1,300,000; Full time

Job summary

Etac Group is seeking a Quality & Regulatory Affairs Manager (PRRC) to lead the Quality, Testing and Regulatory Affairs function at our Anderstorp site. You will own the regulatory framework, drive continuous improvement and serve as PRRC under MDR, reporting to the SVP Mobility Europe & RoW.

You will guide a seven‑person team, collaborate across Operations, R&D, Supply Chain and Product Management, and ensure compliance, cost efficiency and user safety in a growing international medical device

Qualifications

• 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.
• University degree in engineering or relevant scientific discipline, or equivalent experience meeting PRRC requirements 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.

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 MDR compliance, 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.

Skills

Medical device regulations

ISO 13485

MDR compliance

Quality management

Regulatory leadership

Auditor liaison

English proficiency

Education

Engineering degree or equivalent

Job description

Etac Group is seeking a Quality & Regulatory Affairs Manager (PRRC) to lead the Quality, Testing and Regulatory Affairs function at our Anderstorp site. You will own the regulatory framework, drive continuous improvement and serve as PRRC under MDR, reporting to the SVP Mobility Europe & RoW.

You will guide a seven‑person team, collaborate across Operations, R&D, Supply Chain and Product Management, and ensure compliance, cost efficiency and user safety in a growing international medical device