Medical Device Risk Manager - Freelancer (m/f/d)

Roche UK

Vienna, Austria
Not specified; not specified; not specified
Minimum 3 years medical device risk management experience
Profound knowledge of iso 14971 standard
Experience with eu mdr and fda regulations
The role involves supporting overall Risk Management efforts at mySugr in accordance with ISO14971 for EU class IIb and IIa medical devices

Job Summary

  • The role involves supporting overall Risk Management efforts at mySugr in accordance with ISO14971 for EU class IIb and IIa medical devices.
  • You will work with cross-functional product development teams to apply Risk Management during all design phases for new products and updates.
  • Roche offers an innovative agile working environment with opportunities for professional growth and a culture of learning and sharing.

Matching Summary

The role involves supporting overall Risk Management efforts at mySugr in accordance with ISO14971 for EU class IIb and IIa medical devices.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Minimum 3 years Medical Device Risk Management experience
  • Profound knowledge of ISO 14971 standard
  • Experience with EU MDR and FDA regulations
  • Technical documentation skills in regulated quality systems
  • Ability to manage multiple overlapping projects

Nice-to-have

  • Passion for innovative apps or software development
  • Knowledge of the diabetes industry
  • Experience working in startup environments
  • Energetic and outgoing personality
  • Confident speaking in front of others

Key Requirements

  • Minimum 3 years professional experience in Medical Device Risk Management
  • Class II/III device experience in EU and/or US markets
  • Bachelor's degree or equivalent experience preferred
  • Master's degree with several years of related experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter