Research Associate (m/f/d) Regulatory Science

Ear Research Center Dresden (ERCD); Dresden; On-site; EUR 52,000 - 64,000; Full time

Benefits offered by this job

TV-L pay

30 days vacation

Professional development

Team culture and events

Mobility subsidy

Health and wellness programs

Employee discounts

Flexible work arrangements

Job summary

The Ear Research Center Dresden (ERCD) invites applications for a position embedded in a 24-month public-private project. You will conduct independent research in medical device regulatory science, focusing on AI-enabled health tech and digital twins for personalised care in multiple sclerosis.

Collaboration with clinical and industry partners is essential to integrate regulatory requirements into development processes.

Qualifications

• Master's degree or equivalent in a relevant field.
• Strong interest in medical device regulation, AI in healthcare, digital health, and clinical translation.
• Excellent written and spoken English; ability to communicate results clearly.
• Independent, careful, and structured work style with strong teamwork and communication.
• Experience with medical device regulation or relevant standards is advantageous.

Responsibilities

• Conduct independent scientific research in medical device regulatory science.
• Analyze European regulatory requirements and standards for AI-enabled digital health technologies and medical device software.
• Develop and evaluate approaches to integrate regulatory requirements and quality-management into AI-based tech and digital twins.
• Contribute to a risk-based quality-management framework and Quality Manual for R&D activities.
• Investigate transition of research outputs into regulated development processes.
• Collaborate with clinical, technical, academic, and industry partners to identify regulatory requirements.
• Contribute to interdisciplinary workshops and stakeholder activities related to regulatory compliance and quality management.
• Publish scientific results and present at national and international meetings.
• Participate actively in an interdisciplinary and international research environment.

Skills

Analytical skills

English proficiency

Teamwork and communication

Independent and structured work

Regulatory science interest

Education

Master's degree in health sciences / biomedical engineering / digital health / medicine / life sciences / regulatory science

Job description

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.

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.

Aufgaben

• 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

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

Wir bieten

at the Else Kröner Fresenius Centrum for Digital Health

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.

• 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

Important note

Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.