Research Associate (m/f/d) Regulatory Science

Research Associate (m/f/d)

at the Else Kröner Fresenius Centrum for Digital Health

Regulatory Science for AI-enabled Digital Health Technologies

The position is to be filled as soon as possible on a full-time or part-time basis for an initial fixed term of 24 months, with the option of extension and long-term collaboration. Remuneration is based on the provisions of the Collective Agreement for the Public Service of the Federal States (TV-L); placement in pay group E13 is possible subject to the fulfillment of personal requirements. Opportunities for pursuing a doctorate are regulated separately and are not part of the job advertisement.

The Medical Device Regulatory Science research group led by Prof. Stephen Gilbert focuses on regulatory science for software and artificial intelligence in healthcare, including medical device software and clinical decision-support systems, as well as environmental sustainability and green AI.

The position is embedded in a newly funded public-private research project that develops AI-supported, multimodal approaches and digital twins to improve personalised care in multiple sclerosis. The project integrates longitudinal clinical, imaging, molecular and digital data to support prediction of disease trajectories, treatment response and clinically meaningful decision support.

Your responsibilities:

• Conduct independent scientific research in the field of medical device regulatory science
• Analyse applicable European regulatory requirements, guidance and standards for AI-enabled digital health technologies, medical device software and related diagnostic technologies.
• Develop and evaluate approaches for integrating regulatory requirements and quality-management principles into the development of innovative AI-based technologies and digital twins.
• Contribute to the development and implementation of a proportionate quality-management framework and Quality Manual for research and technology development activities.
• Investigate how research outputs can transition from exploratory development into structured, documented and regulatory-ready development processes.
• Work closely with clinical, technical, academic and industry partners to identify regulatory requirements and integrate them into technology development and validation.
• Contribute to interdisciplinary workshops, partner training and stakeholder activities related to regulatory compliance and quality management.
• Develop scientific publications and conference contributions and present research results at national and international scientific meetings.
• Participate actively in an interdisciplinary and international research environment

Your profil:

• Successfully completed university degree (Master's, Diploma or equivalent) in a relevant field such as health sciences, biomedical engineering, digital health, medicine, life sciences, public health, regulatory science or a comparable discipline
• Strong interest in medical device regulation, artificial intelligence in healthcare, digital health and clinical translation
• Very good analytical skills and the ability to work with complex scientific, technical and regulatory topics
• Excellent written and spoken English and the ability to communicate scientific results clearly
• Independent, careful and structured way of working as well as strong teamwork and communication skills
• Experience with medical device regulation, the EU AI Act, quality management or relevant standards is advantageous
• Experience with qualitative or quantitative research methods and scientific publishing is advantageous
• German language skills are advantageous but not required

We offer:

• Compensation:  Based on the TV-L collective bargaining agreement in pay grade  E13 , plus an annual bonus, provided you meet the personal requirements
• Vacation:  30 days of paid vacation
• Professional Development:  Extensive internal and external training and development opportunities to continuously strengthen your skills
• Company Culture:  We value transparency, team spirit, and shared success. Celebrate with us at company gatherings or sporting events like the Rewe Team Challenge
• Mobility: A subsidy for a job ticket to make your commute eco-friendly and convenient
• Health:  We promote your well-being with modern fitness and exercise programs at our health center, mental health programs, and a comprehensive workplace health management program
• Shopping benefits:  Take advantage of employee discounts at our clinic pharmacy, exclusive corporate benefits, and other shopping portals
• Work-life balance: Our Family Office supports you with questions regarding daycare spots, vacation programs, and caring for family members. We also offer flexible work arrangements

Please address your cover letter to Prof. Stephen Gilbert (Professor for Medical Device Regulatory Science).