Senior Expert Risk Management & Control Strategy

Novartis

Schaftenau, Austria
Minimum: €65,604.54pyear; actual: significantly hi...
Onsite
Iso 14971 risk management expertise
Eu mdr and fda regulatory knowledge
Device and combination product experience
Novartis is seeking a Senior Expert in Risk Management & Control Strategy to join their team in Schaftenau, Austria. The ideal candidate will have extensive experience in medical device risk management, particularly with regulatory standards, and will play a crucial role in ensuring patient safety and product quality throughout the device development lifecycle

Job Summary

  • This role serves as a technical authority to shape risk identification, assessment, and control strategies across the device development lifecycle.
  • The position requires defining and challenging risks while ensuring robust compliance with ISO 14971, EU MDR, and FDA expectations.
  • Candidates will provide expert guidance on residual risk justification and support health authority submissions and inspection readiness.

Matching Summary

Match Score: 85

Novartis is seeking a Senior Expert in Risk Management & Control Strategy to join their team in Schaftenau, Austria. The ideal candidate will have extensive experience in medical device risk management, particularly with regulatory standards, and will play a crucial role in ensuring patient safety and product quality throughout the device development lifecycle.

Salary

Minimum: €65,604.54/year; Actual: Significantly higher based on experience; Not specified

Skills & Requirements

Must-have

  • ISO 14971 risk management expertise
  • EU MDR and FDA regulatory knowledge
  • Device and combination product experience

Nice-to-have

  • Cross-functional stakeholder influence
  • Mentoring junior experts capability
  • Experience with autoinjectors or inhalers

Key Requirements

  • Advanced degree in engineering or life sciences
  • Extensive hands-on medical device risk management experience
  • Strong working knowledge of Quality-by-Design principles

Work Rights

Not specified

Tailored Resume

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