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MYmySugr GmbH

Medical Device Risk Manager(m/w/x)

Wien
Part-time, Full-timeFreelanceOn-siteExperienced

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

  • 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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