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Medical Device Risk Manager(m/w/x)
Maintaining risk files for class IIa and IIb medical devices, ensuring ISO 14971 compliance at a medical device firm focused on early diagnosis. 3 years experience managing risk for medical devices required. Family-friendly career paths, flexible modern workplace.
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
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 14971
- IEC 62304
- IEC 62366
- ISO 13485
- MDR
- FDA
Benefits
Other Benefits
- Healthy, equal and inclusive environment
Family Support
- Family friendly career paths
Sustainability Focus
- Sustainability
Healthcare & Fitness
- Healthy lifestyle
Modern Office
- Flexible modern workplace
Learning & Development
- Culture of learning and sharing
- Professional and personal development
Informal Culture
- Open and candid feedback
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Medical Device Risk Manager(m/w/x)
Maintaining risk files for class IIa and IIb medical devices, ensuring ISO 14971 compliance at a medical device firm focused on early diagnosis. 3 years experience managing risk for medical devices required. Family-friendly career paths, flexible modern workplace.
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
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- ISO 14971
- IEC 62304
- IEC 62366
- ISO 13485
- MDR
- FDA
Benefits
Other Benefits
- Healthy, equal and inclusive environment
Family Support
- Family friendly career paths
Sustainability Focus
- Sustainability
Healthcare & Fitness
- Healthy lifestyle
Modern Office
- Flexible modern workplace
Learning & Development
- Culture of learning and sharing
- Professional and personal development
Informal Culture
- Open and candid feedback
About the Company
mySugr GmbH
Industry
Healthcare
Description
The company is committed to transforming healthcare through sustainable action and innovation, focusing on early diagnosis and targeted treatments.
Not a perfect match?
- mySugr GmbH
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