Minimum 3 years medical device risk management experience
Profound knowledge of iso 14971 standard
Experience with eu mdr and fda regulations
mySugr GmbH, a part of Roche, is seeking a Medical Device Risk Manager in Vienna, Austria. The role requires expertise in Medical Device Risk Management to ensure compliance with relevant regulations and standards while fostering a collaborative environment
Job Summary
You will ensure compliance with the Medical Device Risk Management process for EU class IIb and IIa medical devices.
The role involves working with cross-functional product development teams to apply Risk Management during all design phases.
Roche offers an innovative agile working environment with opportunities for professional growth and a healthy, inclusive culture.
Matching Summary
Match Score: 85
mySugr GmbH, a part of Roche, is seeking a Medical Device Risk Manager in Vienna, Austria. The role requires expertise in Medical Device Risk Management to ensure compliance with relevant regulations and standards while fostering a collaborative environment.
Skills & Requirements
Must-have
Minimum 3 years Medical Device Risk Management experience
Profound knowledge of ISO 14971 standard
Experience with EU MDR and FDA regulations
Technical documentation skills in regulated quality systems
Ability to manage risk management projects and deliverables
Nice-to-have
Bachelor's or Master's degree in related field
Knowledge of diabetes industry or health tech
Experience working in startup environments
Passion for innovative apps or software development
Energetic and outgoing personality with team spirit
Key Requirements
Minimum 3 years professional experience in Medical Device Risk Management
Class II/Class III device experience in EU and/or US markets
Proficiency in ISO 14971, IEC 62304, IEC 62366, and ISO 13485
Excellent written and verbal communication skills in English