Team Leader Regulatory Affairs (m/f/d)

In this position, as a team leader, you design global approval strategies for medical devices in the areas of anesthesia, intensive and heat therapy. You run a 13-person Regulatory Affairs team and introduce your leadership, consulting skills and practical experience. Your goal: accelerate market access, ensure compliance with all regulations and maintain existing authorisations at national and international level responsibly. As part of the Therapy business unit, you make a decisive contribution to the success of our company and to the improvement of healthcare. You develop and manage global licensing and re-registration strategies and control their implementation to the final documentation (except the US market). As a professional and disciplinary leadership, you develop your Regulatory Affairs team (13 employees) and promote modern, sustainable structures, processes and methods. You are a forward-looking consultant and competent representative for regulatory issues within the business unit and at international locations – targeted, empathic and passionate. You actively accompany the exchange with authorities (national and international) and take responsibility in strategically significant or challenging situations. You are constantly developing and your knowledge of regulatory requirements and modern methods, and are specifically involved in the work of the Business Unit. You support your team operationally (approximately 50%) and take part and products independently to achieve goals and relieve colleagues.

You have a completed study with technical or scientific orientation – or a comparable qualification. You bring many years of professional experience and ideally first leadership practice in an internationally oriented regulatory affairs function. You have well-founded and up-to-date know-how on international approval requirements, product liability and relevant standards and regulations of medical technology (e.g. ISO 13485, ISO 14971, 21 CFR Part 820, MDR). You have very good knowledge of regulatory software and databases and master English in a safe manner. Your sovereign communication strength, your secure stakeholder management, and your clear target and result orientation are the key to you as an expert. .