Hfue Associate Director

Sanofi Consumer Healthcare

Morristown, NJ, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
10+ years medical device human factors experience
Mastery of fda hf guidance documents
Iec 62366-1:2015+a1:2020 compliance expertise
This role bridges deep technical expertise with strategic leadership to shape team processes and mentor HF/UE professionals across Sanofi's product portfolio

Job Summary

  • This role bridges deep technical expertise with strategic leadership to shape team processes and mentor HF/UE professionals across Sanofi's product portfolio.
  • The incumbent will drive user-centered design processes ensuring product safety and effectiveness through rigorous application of human factors engineering from early engagement through lifecycle management.
  • Sanofi offers a thoughtful rewards package including high-quality healthcare, wellness programs, and at least 14 weeks' gender-neutral parental leave alongside opportunities for international growth.

Matching Summary

This role bridges deep technical expertise with strategic leadership to shape team processes and mentor HF/UE professionals across Sanofi's product portfolio.

Salary

Base: $148,500.00 - $214,500.00; Bonus/Equity: Not specified; Benefits: Eligible for Company employee benefit programs

Skills & Requirements

Must-have

  • 10+ years medical device human factors experience
  • Mastery of FDA HF Guidance documents
  • IEC 62366-1:2015+A1:2020 compliance expertise
  • ISO 14971:2019 risk management knowledge
  • Leading generative formative summative studies
  • Conducting use-related risk analysis (URRA)
  • Cross-functional team leadership and mentoring

Nice-to-have

  • Experience leading FDA submissions interactions
  • Portfolio-level HF/UE strategic governance
  • Knowledge of IFU instructional design
  • Background in industrial or systems engineering
  • Clinical practice or post-market activity experience
  • Strong influence on organizational direction

Key Requirements

  • Bachelor's degree in Engineering Psychology Design Life Sciences
  • 10+ years progressive experience in medical device human factors
  • Proven ability to lead complex HF/UE programs with minimal oversight
  • Excellent written and spoken English communication skills
  • Willingness to travel up to 20% to study sites

Work Rights

Not specified

Tailored Resume

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