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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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ISO 14971
- IEC 62304
- IEC 62366
- ISO 13485
- MDR
- FDA
Benefits
Sonstige Vorteile
- Healthy, equal and inclusive environment
Familienfreundlichkeit
- Family friendly career paths
Fokus auf Nachhaltigkeit
- Sustainability
Gesundheits- & Fitnessangebote
- Healthy lifestyle
Modernes Büro
- Flexible modern workplace
Weiterbildungsangebote
- Culture of learning and sharing
- Professional and personal development
Lockere Unternehmenskultur
- Open and candid feedback
Noch nicht perfekt?
- mySugr GmbHVollzeit/TeilzeitFreelancenur vor OrtBerufserfahrenWien
- mySugr GmbH
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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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- ISO 14971
- IEC 62304
- IEC 62366
- ISO 13485
- MDR
- FDA
Benefits
Sonstige Vorteile
- Healthy, equal and inclusive environment
Familienfreundlichkeit
- Family friendly career paths
Fokus auf Nachhaltigkeit
- Sustainability
Gesundheits- & Fitnessangebote
- Healthy lifestyle
Modernes Büro
- Flexible modern workplace
Weiterbildungsangebote
- Culture of learning and sharing
- Professional and personal development
Lockere Unternehmenskultur
- Open and candid feedback
Über das Unternehmen
mySugr GmbH
Branche
Healthcare
Beschreibung
The company is committed to transforming healthcare through sustainable action and innovation, focusing on early diagnosis and targeted treatments.
Noch nicht perfekt?
- mySugr GmbH
Medical Device Risk Manager(m/w/x)
Vollzeit/TeilzeitFreelancenur vor OrtBerufserfahrenWien - mySugr GmbH
Regulatory Affairs Manager Freelancer(m/w/x)
TeilzeitFreelancenur vor OrtSeniorWien - mySugr GmbH
Regulatory Affairs Manager Freelancer(m/w/x)
TeilzeitFreelancenur vor OrtSeniorWien - Roche Diagnostics GmbH
Compliance Expert(m/w/x)
Teilzeitnur vor OrtBerufserfahrenWienab 60.000 / Jahr - BD Rowa Germany GmbH
Analyst Financial Planning & Analysis(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenFrankfurt am Main, Wien, Kelbergab 126.125 / Jahr