* The Head of Quality and Regulatory is responsible to implement the requirements of Directive 1_D_79 and the SHS requirements in his/her area of responsibility.
* 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 country QT (QM and RA) community and related activities.
* External contacts: contacts with to legal authorities and 3rd parties, e.g. trade associations and certification and standardization bodies. If necessary, contacts to customers (e.g. sales support, complaint and satisfaction management) and suppliers (e.g. workshops/development).
* The Head of Quality and Regulatory is responsible for ensuring full compliance to the local and applicable international regulations and standards affecting SHS products and services.
* He/she is also responsible for monitoring the regulatory environment in order to proactively identify all potential impacts on the SHS business.
* He/she is responsible for local Trade & Professional association activities related to quality and regulatory affairs topics and should drive Siemens Healthineers policies.
* The Head of Quality and Regulatory is also responsible for developing and maintaining excellent and direct relationships with the country Authorities responsible for Medical Devices/In-voter Diagnostic products including related services and acts as the single point of contact between SHS QT, SHS Units and government.
* Ensures full compliance to the SHS related quality and regulatory requirements pertinent to sales and service activities in Country/-ies as described in the Directive 1_D_79 "Quality Management and Quality Policy".
* Supports the organization in the timely execution of Field (Safety) Corrective Actions and proper handling of Medical Vigilance and Post Market Surveillance activities.
* Ensures that all relevant country business and import licenses are in place to allow sales and service of SHS products/services as required.
* Where applicable the Head of Quality and Regulatory participates at the local and relevant trade association activities and interacts with the local Health Authorities with a view to monitor and influences the existing or developing regulations impacting SHS products.
* Where applicable the Head of Quality and Regulatory is responsible for the effective and efficient implementation of the organization's Quality Management System / Management System through documented Manuals, Standard Operating Procedures, and Work Instructions; Maintenance of the integrity of the Quality Management System's / Management System's processes to ensure effective planning, operation, and process control.
* The Head of Quality and Regulatory is also responsible to promote quality consciousness throughout the Country SHS organization as well as systematically collect feedback from business partners/ "internal customers" as a source for continuous improvement.
* Implements quality reporting system for SHS Country Head and SHS QT. Control and report fulfilment of quality requirements and performance. Regular reporting to SHS Country management and use of these results to initiate improvement activities on Country level. Conduct management reviews and initiate necessary corrective actions with Country management.
* Where applicable, maintains ISO 9001/13485 certification(s): creates, monitors, improves and maintains the Quality Management System / Management System in line with SHS QT and SHS Unit requirements; provides direction, authority and leadership on their application.
* Where applicable, acting as the country SHS Management Representative.
* Promotes consciousness throughout the organization of the SHS Business Principles and the SHS QT Vision and Mission.
* Is responsible for ensuring local suppliers of products and services are compliant with regulatory requirements; for ensuring that there is an effective complaint management system; has full authority to put products on hold.
* Be a role-model for the active implementation of HPS (SHS Performance System). Focuses on quantified target achievement in an agile approach, process efficiency using Problem Solving, Value-Stream-Analysis, Stand-Up-Meetings, and visualization. If applicable, responsible for NCC (Non-conformance costs) reporting.
* 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.
* 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 skill