Are you passionate about advancing molecular precision diagnostics for cancer patients? Do you thrive in a dynamic, fast-paced environment, and have first experience in quality management for medical devices? We are looking for a Project Manager to help maintain and further develop our quality management system as we move towards CE-IVD marking for our cutting-edge AI-based medical device software.
Key Responsibilities:
– Lead the maintenance and continuous improvement of our quality management system in compliance with ISO 13485.
– Collaborate with a diverse, interdisciplinary team of biologists, bioinformaticians, and oncologists to ensure high standards of project execution.
– Organize and manage meetings, create agendas, and ensure team members meet timelines.
– Contribute to our regulatory efforts, particularly with respect to CE marking and In Vitro Diagnostic Regulation (IVDR).
What You Bring:
– A Master’s or PhD in Biology, Bioinformatics, Biotechnology, or a related field.
– Experience in quality management, particularly with ISO standards (e.g., ISO 13485).
– Familiarity with In Vitro Diagnostic Regulation (IVDR) is a plus.
– Excellent communication skills and a structured, solution-oriented work approach.
– A proactive, service-oriented mindset, with the ability to adapt to rapidly changing demands.
– Fluency in both German and English, with strong written and verbal communication skills.
– Proficiency in Microsoft Office applications.
What We Offer:
– A challenge – a position in an innovative and fast-growing company at the forefront of molecular diagnostics with the chance to be part of our journey actively shaping the future of cancer diagnostics
– Colleagues – a highly qualified, motivated team in an inspiring work environment in Heidelberg
– Flexibility – part-time and or remote work
If you are driven by innovation and are eager to make a difference in the world of medical diagnostics, we would love to hear from you!
Please contact:
Natalie Jäger
E-mail: natalie.jaeger@epignostix.com
Heidelberg Epignostix GmbH
Nikola-Tesla-Strasse 1
69124 Heidelberg
