Director, Human Factors & Usability for Medical Devices

Sanofi; Northern (KY); Hybrid; USD 179,000 - 258,000; Full time

Job summary

Sanofi is seeking a Human Factors & Usability Engineering Director to lead high-stakes HF/UE programs for drug-device combinations. You will own the full HF/UE lifecycle from user needs to regulatory submission, shaping strategy and driving cross-functional alignment across GDPU.

The role requires deep regulatory experience and a track record of mentoring HF/UE teams. You will collaborate with regulatory authorities and ensure adherence to FDA/EMA guidance while advancing HF/UE as a strategic

Qualifications

• 10+ years in Human Factors and Usability Engineering in drug-device or combination product development.
• Experience supporting regulatory submissions and health authority interactions (FDA/EMA/NMPA).
• Strong knowledge of HF guidance, IEC 62366-1, ISO 14971/13485, and EMA guidelines.

Responsibilities

• Lead complex HF/UE programs across the GDPU portfolio from early needs to Lifecycle Management.
• Drive user needs, use requirements, context of use, URRA, and usability studies end-to-end.
• Regulatory strategy development and health authority engagement support.
• Establish scalable HF/UE processes, tools, and templates across the organization.

Skills

HF/UE leadership

Regulatory submissions

Cross-functional collaboration

Mentoring/people development

Education

Bachelor’s or Master’s in HF/UE or related field

Tools

UEF/DHF documentation

URRA / KUPs analysis

Job description

Sanofi is seeking a Human Factors & Usability Engineering Director to lead high-stakes HF/UE programs for drug-device combinations. You will own the full HF/UE lifecycle from user needs to regulatory submission, shaping strategy and driving cross-functional alignment across GDPU.

The role requires deep regulatory experience and a track record of mentoring HF/UE teams. You will collaborate with regulatory authorities and ensure adherence to FDA/EMA guidance while advancing HF/UE as a strategic