Clinical Affairs Koordinator (m/w/d) in part-time (Specialist Physician - General Surgery)

For our well-known client in Erlangen, we are looking for a Clinical Affairs Koordinator (m/w/d) in part-time at the earliest possible date.

Your area of responsibility

• Planning and coordination of Post-Market Clinical Follow-up (PMCF) and clinical evaluation activities for our medical device portfolio
• Evaluation of clinical data to ensure product safety, performance, and MDR compliance
• Analysis of the need for additional clinical data as well as support in their generation and evaluation
• Creation and maintenance of PMCF plans, PMCF reports, and clinical evaluation documentation
• Evaluation of data from clinical trials, Post-Market Surveillance, and scientific literature
• Close cooperation with Regulatory Affairs, Research & Development, Product Management, Marketing, and external partners

Your profile

• Completed studies in the field of medicine, natural sciences, or engineering
• Several years of professional experience in the clinical or regulatory environment of medical devices
• Good knowledge of the EU-MDR and relevant clinical guidelines (e.g., MDCG)
• Experience in clinical evaluation as well as in Clinical Lifecycle Management
• Knowledge of international regulations (e.g., USA, China) is an advantage
• Ideally experience in the field of Magnetic Resonance Imaging (MRI)
• Basic knowledge in clinical research, study design, and biostatistics
• Very good English skills in speaking and writing, German skills are an advantage
• Strong communication and presentation skills in an international environment
• Ability to translate regulatory requirements into practical processes
• Analytical, structured, and solution-oriented way of working
• High level of personal responsibility, decisiveness, and reliability
• Team-oriented personality with a high orientation toward quality

We offer

• 21 hours per week
• 5 days/week with 4.2 hours of working time each
• Permanent employment contract
• Full social security
• Vacation and Christmas bonuses
• Personal advice and support

Additional information: Requirements for the applicant: Basic knowledge: Sampling, diagnosis Advanced knowledge: Medical laboratory work, Diagnostic radiology (medical), Radiology (medical), Computed Tomography (CT), Sonography, lecturing, health prevention (prevention), patient care, Neuroradiology, Quality Management, Invasive-interventional radiology, Medical documentation, Product Management, Project Management Expert knowledge: Research