Drägerwerk AG & Co. KGaA | Germany | 23xxx Lübeck | Permanent position | Full time | Published since: 23.01.2026 on stepstone.de
Teamleiter Regulatory Affairs (m/f/d)
From hospital to industry to firefighters, people around the world rely on our products: state-of-the-art technology that combines real engineering with the digital future. With more than 130 years of experience, heart blood and the courageous ideas of more than 16,000 employees, we are committed to the development of technology for life. In Lübeck, around 5,300 people work for Dräger. It's good to live here. The second largest city (220,000 inhabitants) of Schleswig-Holstein offers you a high quality of living, short paths and many cultural and leisure activities. From here you reach the Baltic Sea in 20 minutes and in just one hour the Elbmetropole Hamburg. Our center in the Moislinger Avenue is surrounded by plenty of green and water. Historical buildings and modern architecture shape the picture. On foot you can reach the Lübeck Old Town (UNESCO World Heritage Site) and the Central Station in just ten minutes. .
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Your tasks • Your profile • What we offer
In this position you shape global admission strategies for medical devices in the areas of anaesthesia. Intensive and thermal therapy equipment. You run a 13-headed Regulatory Affairs team and combine leadership, advice and hands-on implementation (about 50%). Your goal: Accelerate market access and secure compliance as well as maintaining current authorisations - both nationally and internationally. As part of the Business Unit Therapy, you make a decisive contribution to the company's success in medical technology.
Development and responsibility of sub-areas of global admission and re-registration strategies and control of implementation to final documentation (except the US market) professional and disciplinary leadership of the Regulatory Affairs Team (13 employees); Development of structures, processes and methods foresighted advice, as one of the regulatory experts for the business unit and international locations – clearly oriented towards earnings orientation active support of official exchange (national/international) and take over leadership in strategically important or escalated situations continuous development of your knowledge on regulatory requirements and modern methods; targeted integration into the work of the Business Unit Operational cooperation (approximately 50%): Takeover of partial tasks/products for target achievement and team relief
• completed studies with technical or scientific orientation or comparable • long-term professional experience and ideally first leadership practice in an internationally oriented Regulatory Affairs function • well-founded, up-to-date know-how on international approval requirements, product liability and relevant standards/regulations of medical technology (e.g. ISO 13485, ISO 14971, 21 CFR Part 820, MDR) • very good knowledge of regulatory software and databases as well as knowledge of English • sovereign communication strength, secure stakeholder management and clear goal /result orientation
Location
 | Drägerwerk AG & Co. KGaA | |
| 23558 Lübeck | ||
| Germany |
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