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mySugr GmbH
5d ago

Medical Device Risk Manager(m/w/x)

Wien
Part-time, Full-timeFreelanceOn-siteExperienced

Description

You will safeguard product safety by managing risk files for medical devices and collaborating with development teams to ensure every design phase meets rigorous international standards.

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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

Education

Bachelor's degree
OR
Master's degree

Work Experience

3 years

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

Tools & Technologies

ISO 14971IEC 62304IEC 62366ISO 13485MDRFDA

Languages

English – Business Fluent

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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