Ärztliche Unterstützung / Medical Advisor (m/w/d)
Core
Provides medical expertise to support Clinical Operations and Therapy in planning, conducting, evaluating, and documenting clinical studies, as well as addressing medical-regulatory questions for medical devices and DiGA.
Role type
Medical Advisor (Clinical Reviewer)
Builds
Clinical study designs, medical reviews of protocols and data, regulatory submissions, and quality assurance documentation for medical devices.
Domain
Medical Devices / DiGA (Digital Health Applications) / Clinical Research (via careerplan.io/jobs/2685639-arztliche-unterstutzung-medical-advisor-mwd-at-ecovery-gmbh)
Required skills
Medical judgment, structured preparation of medical facts for interdisciplinary teams, regulatory understanding (MDR EU 2017/745, GCP, ISO 14155, ISO 13485), medical writing/review capabilities
Preferred skills
Experience in clinical studies (medical devices/DiGA), regulatory processes (DiGA applications), literature research, manual medicine/sports medicine specialization, English for scientific reviews
Technologies
MS Office
Responsibilities
Conduct medical reviews of study protocols and data using the 4-eyes principle; Support the development and medical evaluation of study designs; Assist in regulatory submissions and ethics applications; Evaluate SAEs and protocol deviations; Participate in meetings with external partners and regulatory stakeholders
Seniority
Mid-level, hands-on IC