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Medical Device Risk Manager(m/w/x)
Applying ISO 14971 risk management to class IIa/IIb medical devices across design phases. Strong technical documentation skills required. Family friendly career paths, flexible modern workplace.
Requirements
- Experience in Medical Device Risk Management
- Excellent technical documentation skills
- Risk Management project management skills
- Knowledge of ISO 14971 and standards
- Multitasking and organizational skills
- Structured and detail-oriented work manner
- Passion for understanding people's needs
- 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
- Degree in related field or experience
- Technical understanding of software development
- Medical background as an asset
- Knowledge of diabetes or health industries
Tasks
- Support overall risk management efforts per ISO 14971
- Ensure compliance with the company's risk management process
- Maintain risk management files for class IIa and IIb devices
- Collaborate with cross-functional teams during all design phases
- Apply risk management to new products and updates
- Monitor new medical device regulations and standards
- Drive knowledge transfer on risk management topics
- Manage project planning, deliverables, and priorities
- Moderate risk management sessions and present to groups
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)
Applying ISO 14971 risk management to class IIa/IIb medical devices across design phases. Strong technical documentation skills required. Family friendly career paths, flexible modern workplace.
Requirements
- Experience in Medical Device Risk Management
- Excellent technical documentation skills
- Risk Management project management skills
- Knowledge of ISO 14971 and standards
- Multitasking and organizational skills
- Structured and detail-oriented work manner
- Passion for understanding people's needs
- 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
- Degree in related field or experience
- Technical understanding of software development
- Medical background as an asset
- Knowledge of diabetes or health industries
Tasks
- Support overall risk management efforts per ISO 14971
- Ensure compliance with the company's risk management process
- Maintain risk management files for class IIa and IIb devices
- Collaborate with cross-functional teams during all design phases
- Apply risk management to new products and updates
- Monitor new medical device regulations and standards
- Drive knowledge transfer on risk management topics
- Manage project planning, deliverables, and priorities
- Moderate risk management sessions and present to groups
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.
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