Team Leader Regulatory Affairs (m/f/d) (Engineer - Medical Technology)

Drägerwerk AG & Co. KGaA - Job-ID V000010818

What we are looking for from you

In this position, as a Team Leader, you will design global registration strategies for medical devices in the fields of anesthesia, intensive care, and thermotherapy. You will lead a 13-member Regulatory Affairs team and contribute your leadership strength, advisory competence, and practical experience. Your goal: to accelerate market access, ensure compliance with all regulations, and responsibly maintain existing approvals both nationally and internationally. As part of the Business Unit Therapy, you will make a decisive contribution to the success of our company and to the improvement of healthcare.

• You develop and are responsible for global registration and re-registration strategies and manage their implementation up to the final documentation (except for the US market).
• As a technical and disciplinary leader, you further develop your Regulatory Affairs team (13 employees) and promote modern, sustainable structures, processes, and methods.
• You are a forward-looking advisor and a competent contact person for regulatory topics within the Business Unit and at international locations – purposeful, empathetic, and with passion.
• You actively accompany the exchange with authorities (national and international) and take responsibility in strategically significant or challenging situations.
• You constantly develop yourself and your knowledge of regulatory requirements and modern methods and integrate this specifically into the work of the Business Unit.
• You support your team operationally and independently take on sub-tasks and products to achieve goals together and relieve colleagues.

What you bring with you

• You have a completed degree with a technical or scientific orientation – or a comparable qualification.
• You bring many years of professional experience and ideally initial leadership practice in an internationally oriented Regulatory Affairs function.
• You possess sound and up-to-date know-how regarding international registration 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 possess business-fluent English skills.
• Your confident communication strength, your secure stakeholder management, and your clear goal and result orientation distinguish you as an expert.

Your new workplace

Around 5,300 people work for Dräger in Lübeck. It is a great place to live. The second largest city (220,000 inhabitants) in Schleswig-Holstein offers you a high quality of life, short distances, and many cultural and leisure activities. From here, you can reach the Baltic Sea in 20 minutes and the Elbe metropolis of Hamburg in just one hour. Our headquarters in Moislinger Allee is surrounded by lots of greenery and water. Historical buildings and modern architecture shape the landscape. On foot, you can reach the Lübeck Old Town (UNESCO World Heritage Site) and the main station in just ten minutes.

What you will find with us

• Discounts in regional fitness studios
• Flexible working hours
• Individual induction and onboarding
• Good transport connections & parking spaces
• Private leisure and further education programs
• Mobile working possible
• Attractive pay according to the respective collective agreement including various special payments
• 30 days of vacation entitlement plus company-regulated special leave days

Have we piqued your interest?

Then please apply directly here via our career portal. We look forward to your application! If you have any questions, please contact

Thorsten Borck 04518823822