Device Quality Engineer - Device Risk Management And Surveillance Excellence

Sanofi UK

Cambridge, MA, US
Base: $90,000.00 - $130,000.00; bonus/equity: not ...
5+ years medical device industry experience
3+ years risk management and pms experience
Deep knowledge of iso 14971
This role serves as the global process owner for Device Risk Management, Clinical Evaluation, and Post-Market Surveillance across Sanofi's Global Device and Packaging Unit

Job Summary

  • This role serves as the global process owner for Device Risk Management, Clinical Evaluation, and Post-Market Surveillance across Sanofi's Global Device and Packaging Unit.
  • The successful candidate will ensure all medical devices and drug-device combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle.
  • Sanofi offers a thoughtful rewards package including high-quality healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.

Matching Summary

This role serves as the global process owner for Device Risk Management, Clinical Evaluation, and Post-Market Surveillance across Sanofi's Global Device and Packaging Unit.

Salary

Base: $90,000.00 - $130,000.00; Bonus/Equity: Not specified; Benefits: Eligible for company employee benefit programs

Skills & Requirements

Must-have

  • 5+ years medical device industry experience
  • 3+ years risk management and PMS experience
  • Deep knowledge of ISO 14971
  • Knowledge of MDR and 21 CFR 820
  • BS degree in Engineering or Life Sciences

Nice-to-have

  • MS degree preferred
  • Experience with complaint management
  • French or German language skills
  • FMEA moderation facilitation skills
  • Mentoring and training capabilities

Key Requirements

  • BS degree required, MS plus
  • 5+ years medical device experience
  • 3+ years risk management/PMS experience
  • English proficiency mandatory
  • ISO 14971 expertise required

Work Rights

Not specified

Tailored Resume

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