Uit AanDagelijksWekelijksWat: Financiën, verzekeringen & rechtFrequentie: Dagelijks WekelijksPassion and energy for a great cause are part of our culture and values at Siemens Healthineers.Our employees are part of our unique position as an employer in the medical technology sector. We empower everyone to grow through a common goal based on continuous innovation in healthcare for the benefit of the patient. Our constant evolution is based on more than 100 years of experience in the healthcare field and more specifically in the world of advanced imaging. Our ambition is to grow and learn, and to enable everyone to grow professionally and personally.Head of Quality and RegulatoryThe Head of Quality and Regulatory is responsible for implementing the requirements of Directive 1_D_79 and SHS standards in their area of responsibility.Has country-wide authority for all applicable SHS QT aspects, in coordination with the SHS Country Head and SHS QT.Represents SHS Country Organization in local QT (QM and RA) community and activities.Maintains external contacts with legal authorities, trade associations, certification bodies, and standardization organizations. May also interact with customers and suppliers as needed.Ensures full compliance with local and international regulations and standards affecting SHS products and services.Monitors the regulatory environment to proactively identify potential impacts on the business.Participates in local trade and professional association activities related to quality and regulatory affairs, driving Siemens Healthineers policies.Develops and maintains relationships with national authorities responsible for medical devices and diagnostics, acting as the main contact point.Ensures compliance with quality and regulatory requirements for sales and service activities in the country, as per Directive 1_D_79.Supports organization in executing Field (Safety) Corrective Actions and Medical Vigilance activities.Ensures all necessary licenses for sales and import are in place.Participates in local trade associations and interacts with health authorities to monitor and influence regulations.Implements and maintains the Quality Management System, including ISO 9001/13485 certifications, and acts as the Management Representative if applicable.Promotes quality awareness throughout the organization and collects feedback for continuous improvement.Establishes quality reporting systems, reports performance, and initiates improvement activities.Maintains the integrity of the Quality Management System through documented procedures and processes.Promotes understanding of SHS Business Principles and QT Vision and Mission.Ensures suppliers comply with regulatory requirements and manages product complaints and recalls.Acts as a role model for the SHS Performance System, focusing on target achievement, process efficiency, and problem-solving.ProfielMaster's degree in biomedical sciences, engineering, or equivalent.Strong experience in quality management and communication with authorities in the medical field.Experience as an auditor is preferred.Solid knowledge of ISO13485 and European regulations.Strong leadership and communication skills.Enjoys challenging complex projects with an analytical, efficient, and solution-oriented mindset.Fluent in Dutch and English, with good knowledge of French.AanbodAt least 39 days of leave per year.Competitive salary with fringe benefits such as a company car, fuel card (within Europe), eco vouchers, meal vouchers, and insurance packages.Thorough onboarding and training courses.A pleasant working environment emphasizing work-life balance and fun activities.A culture of lifelong learning encouraging continuous skill development.
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