Description

You will safeguard product safety by managing risk files for medical devices and collaborating with development teams to ensure every design phase meets rigorous international standards.

Requirements

• •3 years Medical Device Risk Management experience
• •Excellent technical documentation skills
• •Management of Risk Management project aspects
• •Knowledge of ISO 14971 and associated standards
• •Multitasking and organizational skills
• •Structured, detailed work manner
• •Passion for interacting with people
• •Energetic and outgoing personality
• •Team spirit and collaborative mindset
• •Confidence in public speaking and moderation
• •Great English communication skills
• •Willingness to work in fast-paced corporations
• •Bachelor's degree, Master's, or equivalent experience
• •Technical understanding of innovative apps
• •Medical background (advantageous)
• •Knowledge of diabetes or health industries

Tasks

• •Support overall risk management efforts per ISO 14971
• •Ensure compliance with internal risk management processes
• •Maintain risk files for class IIa and IIb devices
• •Collaborate with cross-functional product development teams
• •Apply risk management during all design phases
• •Monitor new medical device regulations and standards
• •Drive organizational knowledge transfer on risk topics
• •Manage project risk planning, deliverables, and priorities
• •Organize and execute multiple overlapping projects
• •Identify inconsistencies through detailed, structured analysis
• •Moderate professional risk management sessions

Tools & Technologies

Benefits