You will ensure compliance with the Medical Device Risk Management process of mySugr and maintain Risk Management files for EU class IIb and IIa medical devices
Job Summary
You will ensure compliance with the Medical Device Risk Management process of mySugr and maintain Risk Management files for EU class IIb and IIa medical devices.
You will work with cross functional product development teams to apply Risk Management during all design phases for new products and/or product updates.
We are committed to providing a healthy, equal and inclusive working environment for our employees to bring true relief to the patient!
Matching Summary
You will ensure compliance with the Medical Device Risk Management process of mySugr and maintain Risk Management files for EU class IIb and IIa medical devices.
Skills & Requirements
Must-have
Medical Device Risk Management
ISO 14971 compliance
EU MDR/FDA regulations
cross-functional product development
technical documentation skills
Nice-to-have
passion for innovative apps
knowledge of diabetes industry
startup environment experience
energetic and outgoing personality
team spirit and collaboration
Key Requirements
Minimum 3 years experience in Medical Device Risk Management
Proficient in ISO 14971
Familiarity with associated standards and regulations
Ability to manage project risk aspects
Excellent written and verbal communication in English