You take on the role of Information Security Officer (ISO) and shape our security strategy.

You independently plan and manage the RA&QA budget.

As PRRC (Person Responsible for Regulatory Compliance), you bear the regulatory responsibility for our software products according to MDR.

You are responsible for building, maintaining, and further developing our technical documentation in compliance with international standards such as IEC 62304, ISO 14971, ISO 13485, IEC 62366, among others.

You lead projects for audit preparations and certifications, e.g., according to ISO 13485 or ISO 27001.

You take responsibility for our Quality Management System (QMS) and CAPA processes for continuous improvement.

You ensure that our products meet and maintain the DiGA reimbursement status in Germany.

Together with data protection coordination, IT, and engineering, you work on cybersecurity strategies that effectively protect our products and data.

Several years of experience in regulatory affairs and quality management for medical devices, ideally with a focus on software (SaMD).

In-depth knowledge of relevant standards: MDR, ISO 13485, ISO 14971, IEC 62304, ISO 27001.

Experience with digital health applications (DiGA) and regulatory submission at BfArM.

Project management skills and a structured working style.

Fluent German and very good English skills.

Hands-on mentality and team spirit in a dynamic, agile environment.

Trust - We believe in the talents we hire. You receive a permanent contract. Home office is easily possible.

Rest - 29 vacation days in the first year, after one year at Kranus you get an additional day for your rest.

Body & Mind - You get an "Urban Sports Club" membership & access to the meditation app "Headspace".

Future - We support your company pension scheme & gladly inform you about the benefits.

Impact - Work with purpose? Together with you, we improve patient healthcare every day.

Teamwork - You are part of a highly motivated team with flat hierarchies and lots of fun at work.

Our goal at Kranus Health is to treat health problems in men and women using integrated digital therapy solutions, close the digital gap in urology, and help millions of patients lead better and longer lives.

With a market presence in both Germany and France, Kranus Health is one of the best-financed DiGA companies in Germany, successfully extending its Series A financing round with a total volume of over 22 million US dollars in just 3 years since its founding.

With a growing product portfolio and an internationalization strategy, Kranus Health offers the opportunity to have a very real and scalable impact on patients' lives and to help shape a dynamic and modern working environment.

Do you want to revolutionize the healthcare industry with us? Then apply now with your resume! We look forward to hearing from you!