Industry Insights · September 2026 · By the Aleph University Team · 5 min read
The U.S. medical device industry employs close to 800,000 people and pays well above the national average. Every device it makes needs someone who knows how to take it through regulatory approval.
This article brings together public data from the Bureau of Labor Statistics (BLS), DataUSA, the Regulatory Affairs Professionals Society (RAPS) and the FDA to show what the job market looks like for people building careers in regulatory affairs, quality assurance and medical device innovation in the United States.
The main figures
| Indicator | Figure | Source |
|---|---|---|
| Workers in medical equipment and supplies manufacturing | 797,843 | DataUSA, 2024 |
| Average salary in the sector | $97,864 per year | DataUSA, 2024 |
| Projected growth in healthcare and social assistance | +9.5% (2025–2035) | BLS |
| Regulatory affairs professionals in the U.S. | 31,133 | RAPS, 2024 |
| AI-enabled devices authorized by the FDA | About 1,450 by the end of 2025 | FDA list, third-party count |
The size of the sector
According to DataUSA, medical equipment and supplies manufacturing employed 797,843 people in the United States in 2024. The average salary was $97,864 a year, about $28,000 above the national average of $69,878.
Much of that workforce is in production and assembly, but the sector also depends on engineers, quality specialists, regulatory professionals and managers. Those are the roles where specialized graduate training makes the biggest difference.
Where the growth is
The BLS Employment Projections for 2025–2035 expect total U.S. employment to grow 3.5%. The healthcare and social assistance sector is projected to grow 9.5% and add more than 2.2 million jobs, the second-fastest growth rate of any sector and by far the largest in number of jobs.
For occupations close to the medical device industry, the BLS reports the following:
| Occupation | Median pay (May 2025) | Projected growth 2025–2035 |
|---|---|---|
| Medical and health services managers | $123,860 | +24% |
| Bioengineers and biomedical engineers | $109,370 | +8% |
| Compliance officers | $80,730 | +4% |
Medical and health services managers stand out: about 640,400 jobs in 2025 and around 62,300 openings a year over the decade. Biomedical engineering is a small occupation (about 23,800 jobs), but it is growing much faster than the average.
Why regulatory affairs matters
Without regulatory approval, no device reaches the market. That makes regulatory affairs one of the functions the whole industry depends on.
The 2024 workforce report by RAPS and Elemed counted 124,436 regulatory professionals worldwide and 31,133 in the United States. Medical devices account for 21% of them, compared with about 70% in pharmaceuticals and just under 9% in biotechnology. The report also found that 25% of regulatory professionals were open to new work, up from 15% in 2021, a sign of an active job market.
Two trends add to the demand:
- Artificial intelligence. The FDA keeps a public list of AI-enabled medical devices. Independent counts of that list put the total at about 1,450 devices by the end of 2025, with around 295 authorized in 2025 alone. Each one needed a regulatory strategy.
- International rules. The European Union’s Medical Device Regulation (EU MDR) continues to raise demand for professionals who can handle requirements in more than one market.
The BLS does not track regulatory affairs as a separate occupation. Salary portals put the average U.S. salary for regulatory affairs roles at roughly $95,000 to $111,000 a year. We break those figures down in our article on regulatory affairs specialist salaries in the USA and Latin America.
Four career profiles
1. Regulatory affairs specialist
Prepares and manages submissions to the FDA and other agencies. The technical core includes 21 CFR Subchapter H, premarket pathways (510(k), De Novo and PMA), ISO 13485, ISO 14971 and IEC 60601. Our BME-612 Medical Device Regulation certificate (Introductory and Advanced) covers these topics.
2. Quality assurance engineer
Keeps the quality management system working: ISO 13485, risk management under ISO 14971, process validation, audits and corrective actions. It is one of the most common entry points into the industry. These topics are the core of our MS in Regulatory Affairs and Quality Assurance in Medical Technologies.
3. Medical and health services manager
Plans and directs health services and the teams that deliver them. With a median of $123,860 and 24% projected growth, it is one of the strongest occupations in the BLS projections. Combining regulatory knowledge with management skills helps professionals move toward these roles.
4. Biomedical engineer
Designs and improves devices and systems. Engineers who understand the regulatory pathway from the start design products that are easier to test and approve. Our MS in Medical Devices, Regulatory Affairs and Health Information Technologies connects both sides.
Four career strategies based on the data
- Make regulatory affairs your core. It is the function every device depends on, and the market for these professionals is active.
- Build verifiable credentials early. A certificate such as BME-612 or a master’s in regulatory affairs tells an employer exactly which frameworks you know.
- Combine regulatory affairs and quality. Professionals who can move between both functions have more mobility and are harder to replace.
- Document your impact with numbers. Keep track of the processes you led, the submissions you supported and the audit findings you resolved. That evidence is your argument in every salary conversation.
Conclusion
Medical devices save lives, and every year millions of patients depend on someone having taken a device through the regulatory process correctly. The data shows a large, well-paid sector with steady growth, and a constant need for people who understand regulation and quality. For professionals willing to specialize, it is a good time to do it.
Aleph University offers 100% online programs designed for professionals who already have a career in the medical device industry or want to enter it. Request information to learn more about our master’s programs and certificates.
Sources
- DataUSA, Medical Equipment & Supplies Manufacturing industry profile (2024 data)
- U.S. Bureau of Labor Statistics, Employment Projections 2025–2035
- BLS Occupational Outlook Handbook, Medical and Health Services Managers
- BLS Occupational Outlook Handbook, Bioengineers and Biomedical Engineers
- BLS Occupational Outlook Handbook, Compliance Officers
- RAPS and Elemed, 2024 Global Regulatory Affairs Professionals Workforce report
- U.S. FDA, Artificial Intelligence-Enabled Medical Devices list