Manager, Human Factors, Regulatory Affairs

Posted Yesterday
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Washington, DC, USA
In-Office
85K-212K Annually
Senior level
Healthtech
The Role
Lead human factors/usability engineering for regulated medical products: develop usability documentation, plan and run formative and summative studies, analyze data, write reports, support regulatory submissions, review labeling/IFUs, and manage cross-functional teams and external vendors.
Summary Generated by Built In

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 https://jobs.iqvia.com

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. https://jobs.iqvia.com/eoe

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.

Skills Required

  • 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 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.
  • 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.
  • Medical device design experience and clinical shadowing experience.
  • Familiarity with statistical analysis and qualitative research methodologies.

IQVIA Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.

  • Healthcare Strength Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
  • Retirement Support Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
  • Leave & Time Off Breadth Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.

IQVIA Insights

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The Company
HQ: Durham, NC
61,500 Employees
Year Founded: 2016

What We Do

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.

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