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 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.

Our worldwide business offers a wide variety of exciting career opportunities and positions for the person who wants to grow within a group based on a strong culture and values. If you are looking for a flexible and dynamic environment with the desire to take up new challenges and to surpass yourself, do not hesitate to send us your application for the position of:

 

Quality and Regulatory Lead – Medical Devices

 

The mission for the Siemens Healthineers (SHS) Head of Quality and Regulatory is to support the Siemens Healthineers Country Head and Siemens Healthineers Country management in implementing and maintaining the SHS Quality Management System/ Management System and overall regulatory compliance of the SHS business and Development of a country specific quality/regulatory strategy, plans, and targets. He/she keeps up-to-date with national regulations, standards and other relevant requirements, informs SHS QT and the affected SHS units about new/revised requirements. He/she reports directly to the SHS Country Head and becomes part of the management board.

 Your Responsibilities:

Implement Quality: Ensure adherence to Directive 1_D_79 and SHS requirements locally.

 

Lead National Oversight: Manage SHS Quality and Regulatory (QT) activities for Belgium and Luxembourg. 

 

Monitoring Regulatory: Represents SHS Country Organization in local country QT (QM and RA) community and related activities as well as monitoring the regulatory environment. 

 

Maintain Government Relations: Act as main contact with authorities for Medical Devices/IVD products.

 

Manage Licensing: Ensure all necessary business and import licenses are valid.

 

Implement QMS: Maintain and enforce the Quality Management System. 

 

Support Corrective Actions: Assist with safety corrective actions and post-market surveillance.

 

Maintain Certifications: Oversee ISO 9001/13485 certification and quality system improvements.

 

Ensure Supplier Compliance: Verify suppliers meet regulatory and compliance requirements and manage complaints.

 

Lead Performance System: Drive continuous improvement, efficiency, and quality performance metrics.

 

     

Your Profile & Experience:

You hold a master’s degree in biomedical sciences, engineering or other equivalent degree. Strong quality management experience and communication with authorities in medical environment is a prerequisite. Ideally, you have experience as auditor. You have a solid knowledge and understanding of ISO13485 and European regulations. You have strong people management experience, and you have excellent communication skills. You like to be challenged by complex projects. You have an analytical mindset, and you are efficient and solution oriented. Your Dutch and English are fluent, and you have a good knowledge of French.

 

 

What can you expect :

A minimum of 39 days of leave per year. A competitive salary, supplemented with fringe benefits such as a company car, a fuel card (active within Europe), eco vouchers, meal vouchers and a nice package of insurances. A thorough onboarding and various training courses. A pleasant working atmosphere, with an eye for work-life balance and fun activities. A “lifelong learning" culture where you are encouraged to continuously develop your skills.

 Convinced by our company culture as well as the purpose and responsibilities linked to this position? Apply now, we are already looking forward to getting to know you! If this position is not what you are looking for, but you wish to be considered for future needs, don't hesitate to upload your resume in our Talent Community.

Diversity, equality, and inclusion are strong values. We are committed to considering all applications in accordance with these values and in full transparency.

To all recruitment agencies: Siemens Healthineers does not accept resumes from agencies. Please do not forward resumes to the alias of our position, employees, or any other company location. Siemens Healthineers is not responsible for any fees associated with unsolicited resumes.

Belgium's Siemens Healthineers and Varian entities are Great Place to Work® certified and recognised as companies where it's good to work!