Entwicklungsingenieur in der Medizintechnik (w/m/d (w/m/d)
Core
Managing risk management processes, clinical evaluations, and post-market surveillance for medical devices.
Role type
Senior IC medical device regulatory engineer (clinical evaluation & risk management)
Builds
Clinical evaluation reports, risk management files, and post-market surveillance data for medical device clients
Domain
Medical device industry + regulatory compliance
Required skills
Clinical evaluation planning and execution, risk management per ISO 14971, post-market surveillance (PMS) and vigilance, literature research, clinical data collection and analysis, EUDAMED database management
Preferred skills
Audiology domain knowledge, experience with clinical evaluation for medical devices
Technologies
EUDAMED, ISO 14971
Responsibilities
Oversee risk management processes and clinical evaluations including post-market surveillance and vigilance; conduct active market observation and post-market clinical follow-up; plan, create, and update clinical evaluations; perform literature research and analyze clinical data; implement risk management within the quality management system; maintain contact with experts and clients domestically and internationally
Seniority
Senior, hands-on IC