Manager Regulatory Affairs & Quality (m/w/d)

HAPEKO is the first address for professionals and managers in Germany. The focus of the activity is the creation of links between specialists and executives with a professional desire for change and suitable companies. HAPEKO (www.HAPEKO.de) is represented throughout Germany with more than 20 locations.

Our client is a classic ''Hidden Champion'', which is one of the world's leaders in its special glass manufacturing segment with about 200 employees at the Braunschweig site. With medium-sized local structures and an international group in the field of medical technology in the back, one acts here with short decision-making in a long-term safe market environment.

Currently, this company offers the opportunity to become part of a five-member team as Manager Regulatory Affairs & Quality (m/w/d). In this responsible position, you ensure compliance with all regulatory requirements of different markets to the products and thus contribute significantly to the further success of the company.

If this is exactly the challenge that suits you, apply directly! We look forward to meeting you In this position, you are responsible for compliance with all regulatory requirements for the medical devices of our client. You create and process national and international applications for admission as well as regulatory documentation taking into account the applicable legal requirements. The maintenance and development of technical documentation for existing and new products is also one of your tasks. In addition, ensure compliance with relevant standards (e.g. ISO 13485, MDR/IVDR, FDA) and actively promote the further development of the regulatory system. By analyzing quality and risk topics, you are taking appropriate measures and ensuring their effective implementation. You ensure current and complete process documentation and ensure compliance with regulatory requirements. Material requirements and product specifications always keep in mind and ensure their compliance. In close cooperation with development, quality management and product management, ensure the regulatory compliance of the products and support the responsible person according to IVDR. In addition, if necessary, you represent the Quality Manager and take over the management of the Quality team – in case of suitability and interest.

You have completed their studies in the scientific or medical-technical field or comparable training. Multiannual professional experience in Regulatory Affairs, ideally related to medical devices, distinguishes your profile. You bring well-founded knowledge of the approval of medical devices and/or in vitro diagnostics (IVD) and are familiar with the relevant regulations. Experience in dealing with authorities and in carrying out internal and external audits is desirable. Topics such as material declarations, occupational safety, environmental protection or energy management are ideally already familiar to you. You convince by analytical thinking, organisational skills and a structured, independent way of working. communication strength, team orientation and a safe occurrence, even in the international environment, complete your profile; You bring certain knowledge of German and English in word and writing.

An attractive salary package Flexible working hours and the opportunity to become part of a healthy company on a growth course in a crisis-proof industry. Your health is at the heart of your new employer, so there is an extensive health promotion. (e.g. participation in Hansefit and Jobrad). Your personal and professional training is actively supported and supported by the employer both in terms of time and financial terms. JOBV1_EN