Manager, Human Factors, Regulatory Affairs
Job Location:
Washington, DC - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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-functionalinternalteamsandmanageexternal vendorsto deliver complicatedhuman factors studyprojectsand 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
Bachelors 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 withmedical device design experience andclinical 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. 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 $84900.00 - $212200.00. 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.Required Experience:
Manager
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
