IQVIA

Manager, Human Factors, Regulatory Affairs

IQVIA • $84K — $212K *
Washington, DC 20011In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Human Factors Engineering, Human-Computer Interaction, Biomedical Engineering, Psychology, Industrial Engineering, Ergonomics, or related field.
  • 5+ years of experience in human factors engineering or usability engineering.
  • Experience with formative and summative usability studies.
  • Knowledge of FDA Human Factors Guidance, IEC 62366-1, and ISO 14971 principles.
  • Strong analytical skills and technical writing.
  • Excellent verbal and written communication skills; ability to work in cross-functional teams.
  • Experience developing study protocols and human factors reports.

Responsibilities

  • Develop and maintain comprehensive usability engineering documentation.
  • Plan, conduct, and oversee human factors validation studies.
  • Collaborate with internal teams and manage external vendors for complex projects.
  • Support regulatory submissions by preparing relevant human factors documentation.
  • Review product labeling and user materials for clarity and usability.

Benefits

  • Opportunity to manage multiple projects in a fast-paced environment.
  • Exposure to diverse medical device development projects.
  • Collaboration with cross-functional teams and external vendors.
Full Job Description
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.


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.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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