Quality & Regulatory Manager

Über die Tätigkeit

Job mission

Being responsible for managing, planning and organizing quality management system
to comply with all regulations and continuously improve quality of our services.
Ensuring compliance with all regulatory requirements for our products and services in
the regions where we distribute them

Key Responsibility Areas

• Manages corporate quality management programs, including certification processes for ISO 14385 & 15189. Develops and drives continuous improvement to quality system processes through the development, execution, monitoring, and reporting of Quality Plans.
• Undertake and manage regulatory inspections and audits
  Prepare, manage and follow-up audits with the aim of achieving continuous improvement of the quality and processes.
  Supports the efficient and effective execution of the corrective action program, internal audit program, and other QMS subsystem elements, as well as the support of external audits and inspections.
• Translate the strategy into quality in actual projects in the frame of generally accepted quality standards, including standards, GMP, GDP, etc.) with the aim of achieving a continuous improvement.
• Act as a qualified person with the aim of releasing products and analyses.
• Keep up to date with national and international legislation and guidelines. Continuously inform oneself about the latest trends in quality and keep one´s knowledge up to date in function of new developments in this field.
• Develop and implement processes with the aim of receiving approval for product and services.
• Identify compliance issues that require follow up and conduct internal investigation of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues.
• Maintaining regulatory documentation database. Verify that all firm and regulatory policies and procedures have been documented and make sure every employees knows the applicable procedure and work accordingly.
• Maintain good contact with authorities with the aim of anticipating on changes or new developments and trends within the sector.
• Plans and monitors training of people in the QMS and communicate the QMS system within the organization.