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MYmySugr GmbH

Medical Device Risk Manager(m/w/x)

Wien
Part-time, Full-timeFreelanceOn-siteExperienced

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

  • EnglishBusiness 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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of mySugr GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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