Manager, Human Factors, Regulatory Affairs

Responsibilities and Duties 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. Required knowledge, skills, and experiences 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. Preferred Qualifications 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.The potential base pay range for this role, when annualized, is $84,900.00 - $212,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.SummaryLocation: Washington, DC, United States of AmericaType: Full time