YOUR ROLE - WHAT'S WAITING FOR YOU:

 Do you find it enjoyable to work in the nexus of IT and business topics? In order to guide our clients into the digital age, would you also like to actively influence how their fundamental applications and processes in the life sciences (pharmaceuticals, medical devices, and human laboratories) are transformed? If so, adesso is the ideal location for you! In your role as a consultant, you are the link between Regulatory Affairs and implementing IT. Here, you will drive regulatory topics and design the associated business processes for our customers, select the appropriate technologies, assist with the relevant documentation and test our IT solutions.

 In detail, you will be responsible for the following tasks: 

Ensuring compliance issues in the technical documentation of products in accordance with MDR with IEC 62304, ISO 14971, ISO 13485 or GAMP5 with 21 CFR Part 11 and other relevant regulatory requirements of medical IT Strategic advice on the alignment and design of IT and processes (SOPs) for our customers Conception and requirements management of IT systems as well as test management and evaluation of IT security Validation of IT systems in accordance with GAMP5 (CSV or CSA) .

YOUR SKILLS - WHAT YOU BRING TO THE TABLE: 

We don't just think in terms of rigid requirement profiles, which we require point by point. Experience and the project business have shown us that it pays off for everyone to use and develop individual strengths and skills in a team. In addition to a degree in medical technology with a minor in computer science, quality management, natural sciences or comparable qualifications, one thing counts above all: an eye for the essentials and a passion for digital transformation processes as well as the desire to think your way into new topics and discover new technologies, tools, etc. Initial experience in the application of ISO 14971, IEC 62304, IEC 62366 and ISO 13485 or GAMP5 standards Experience in the field of software development or implementation in a regulated environment In addition, you score points with your enthusiasm for learning as well as your open, communicative and helpful nature, your creative power and analytical and conceptual skills. Good written and spoken German and English skills and a willingness to travel for projects round off your profile.