Social network you want to login/join with:Head of Quality and Regulatory (m/f/x), DilbeekClient:Location: Dilbeek, BelgiumJob Category: OtherEU work permit required: YesJob Reference: 02969c8bdf32Job Views: 1Posted: 28.04.2025Expiry Date: 12.06.2025Job Description:Passion 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 evolution is based on over 100 years of experience in healthcare, especially in advanced imaging. We aim to grow, learn, and enable professional and personal development.We offer a wide range of exciting career opportunities in a culture rooted in strong values. If you seek a flexible and dynamic environment with new challenges, consider applying for the position of Head of Quality and Regulatory.Your Responsibilities:Implement Directive 1_D_79 and SHS requirements in your area.Hold country-wide authority for all applicable SHS QT aspects, in coordination with the SHS Country Head and SHS QT.Represent SHS Country Organization in local QT communities and activities.Maintain external contacts with legal authorities, trade associations, certification bodies, and possibly customers and suppliers.Ensure compliance with local and international regulations affecting SHS products and services.Monitor the regulatory environment for potential impacts on SHS business.Participate in trade association activities and interact with health authorities to influence regulations.Develop and maintain relationships with authorities responsible for Medical Devices/In-vitro Diagnostic products.Ensure all licenses for sales and service are in place.Implement and maintain the organization's Quality Management System / Management System.Promote quality consciousness and collect feedback for continuous improvement.Implement quality reporting systems and conduct management reviews.Maintain ISO 9001/13485 certifications where applicable.Act as the country SHS Management Representative if applicable.Promote SHS Business Principles and QT Vision and Mission.Ensure compliance of local suppliers, manage complaints, and have authority to put products on hold.Focus on process efficiency, problem solving, and continuous improvement using HPS and NCC reporting.Your Profile & Experience:Master’s degree in biomedical sciences, engineering, or equivalent.Strong quality management experience and communication with authorities.Experience as an auditor is preferred.Solid knowledge of ISO13485 and European regulations.Excellent people management and communication skills.Ability to handle complex projects with an analytical, efficient, and solution-oriented mindset.Fluent in Dutch and English, with good knowledge of French.What can you expect:At least 39 days of leave per year.Competitive salary with benefits like a company car, fuel card, vouchers, and insurances.Thorough onboarding and training.A pleasant work environment supporting work-life balance and activities.A culture of lifelong learning and continuous development.If you are convinced by our culture and the responsibilities of this role, apply now. We look forward to meeting you! If this role isn't for you but you'd like to be considered for future opportunities, please upload your resume. We value diversity, equality, and inclusion, and consider all applications transparently.Note to recruitment agencies: Siemens Healthineers does not accept resumes from agencies. Please do not forward resumes to our positions or employees. We are not responsible for fees related to unsolicited resumes.Our entities in Belgium are Great Place to Work certified and recognized as excellent workplaces!
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