Manager, Human Factors, Regulatory Affairs

IQVIA•Washington, DC

3d•$84,900 - $212,200

About The Position

This role focuses on Human Factors engineering within Regulatory Affairs, specifically for medical devices. The Manager will be responsible for developing and maintaining crucial documentation related to usability and user safety, planning and executing validation studies, collaborating with internal and external teams, and supporting regulatory submissions. The position requires a strong understanding of regulatory guidelines and principles of usability engineering to ensure product safety and effectiveness.

Requirements

Bachelor's degree in Human Factors Engineering, Human-Computer Interaction, Biomedical Engineering, Psychology, Industrial Engineering, Ergonomics, or a related field.
5+ years of experience in human factors engineering, usability engineering, user experience research, or a related discipline.
Experience conducting formative and summative usability studies.
Knowledge of FDA Human Factors Guidance (2016 & 2026), IEC 62366-1, ISO 14971, and applicable usability engineering principles.
Strong analytical, problem-solving, and technical writing skills.
Excellent verbal and written communication skills and the ability to work effectively in cross-functional teams.
Experience developing study protocols, moderator guides, risk analyses, and human factors reports.
Ability to manage multiple projects concurrently and work independently in a fast-paced environment.

Nice To Haves

Experience with combination products, drug delivery devices, digital health technologies, surgical systems, or other regulated medical devices.
Experience supporting regulatory submissions to FDA, EU MDR, or other global regulatory agencies.
Advanced degree (M.S. or Ph.D.) in Human Factors, Ergonomics, Psychology, Biomedical Engineering, or a related field.
Experience interacting with healthcare professionals, patients, and caregivers during user research activities.
Candidate with medical device design experience and clinical shadowing experienced is highly preferred.
Familiarity with statistical analysis and qualitative research methodologies.

Responsibilities

Develop and maintain usability engineering documentation, including use-related risk analyses, task analyses, user profiles, use specifications, and human factors engineering reports.
Plan, conduct, and oversee human factors validation (summative) studies, including protocol development, participant recruitment, study moderation, data analysis, and report generation.
Collaborate with cross-functional internal teams and manage external vendors to deliver complicated human factors study projects and regulatory submission projects.
Support regulatory submissions by preparing human factors documentation and responding to regulatory authority questions related to usability and user safety.
Review product labeling, instructions for use (IFUs), training materials, and user interfaces to ensure clarity, consistency, and usability.