National Quality and Regulatory Manager

Core functions

• Ensures that the quality management system demonstrates regulatory compliance per ISO 15189, and other applicable regulations and standards from customers.
• Follows group policies and procedures.
• Promotes a culture of quality by educating others in quality management system fundamentals, programs and tools.
• Develop quality goals and objectives in collaboration with Group and local functional heads, assists in execution of these goals and report results and any need for improvement to hierarchical superiors.
• Prepare quality meeting data/presentation.
• Conducts Quality Management Review meeting at least once per year in cooperation with laboratory management and Country Leadership Team.
• Ensures non-conformances, adverse events and complaints are identified and documented and that timeliness requirements are met. Assess risk, assists in root cause analysis and corrective action efforts. Monitors trends and create reports for periodic quality meeting and management review.
• Plan and take part in internal audits. Follow-up of actions following audits.
• Participates in the preparation of accreditation dossiers, accompany auditors (e.g. ISO quality inspectors) during audits of the laboratories and coordinates responses to audit findings.
• Reviews / approves standard operating testing procedures and change controls before release.
• Ensures regulatory compliance of all laboratories by maintaining up-to-date knowledge of requirements and coordinating activities to fulfill requirements.
• Coordinates the implementation of the European In-Vitro Diagnostic Regulation in all laboratories, ensuring the compliance of the in-house devices with the Art 5(5) of the European In-Vitro Diagnostic Regulation (IVDR).
• Monitors in collaboration with procurement team the compliance readiness of suppliers of commercial CE-IVD devices with IVDR.
• Ensures appropriate implementation of the risk management procedure in all laboratories.
• Performs other duties as assigned.

Leadership

• Sets the overall direction for the standardization and harmonization of quality related processes considering the Group quality strategy and the big picture of internal and external aspects
• Identifies and drives changes in a future-oriented, solution-oriented and proactive manner
• Creates an open-minded atmosphere to allow innovative thinking by encouraging others to express their individual point of view, listens carefully to extract business potentials.

Organization

• Reporting line: Head Quality and Regulatory Affairs Nordics Cluster
• Location: Oslo
• Full time position

Education, Experience and Skills

• Bachelor’s degree or master’s degree in a technical/ process engineering/QA discipline, with significant related professional experience within the laboratory environment.
• Prior in-depth experience working in an ISO 15189 accredited testing laboratory and with a focus on Quality Management Systems.
• Ideally experience with medical device regulation and/or in-vitro diagnostic directive regulation
• Excellent interpersonal, organizational & communication skills with excellent attention to detail.
• Responsive problem solver and action oriented.
• English fluent as a must (presenting, writing, reading).
• Minimum Years Recommended and/or Preferred: 3-5 years