Regulatory and Quality teams aren’t hiring for “people who have read the rules” anymore. They’re hiring for professionals who can apply them—under pressure, with real timelines, and real consequences.
And right now, the pressure is very real:
- The FDA has issued the Quality Management System Regulation (QMSR) final rule, aligning 21 CFR Part 820 more closely with ISO 13485.
- The EU Medical Device Regulation (MDR) continues to raise the bar for technical documentation, clinical evaluation, and post-market expectations.
So if you’re building (or rebuilding) your career in Medical Devices, this is exactly the moment where a specialized master’s degree can stop being “education” and start becoming a career advantage—when it’s designed for the way the industry actually operates.
1) A curriculum built for the full product lifecycle (not generic theory)
The Aleph University online M.Sc. in Regulatory Affairs & Quality Assurance in Medical Technologies is designed as a technical deep dive across the lifecycle—from early development to market access to post-market compliance.
Expect to work through the areas that show up in real roles:
Global regulatory strategy
- U.S. pathways, including the Quality System Regulation framework under 21 CFR Part 820.
- EU market context under MDR.
Quality management systems
- Core principles aligned with ISO 13485, the internationally recognized QMS standard for medical devices.
Risk management you can actually use
- Practical risk thinking grounded in ISO 14971, which defines the process for risk management across the device lifecycle.
This isn’t about memorizing acronyms. It’s about being able to walk into a meeting and confidently answer:
“What’s the risk? What’s the control? What’s the evidence?”
2) Beyond the textbook: the Sigma Scientific connection
One of the most differentiating angles here is that Aleph isn’t positioned as a purely academic bubble.
Through strategic alignment with Sigma Scientific Services, students are exposed to insights from an active, A2LA-accredited testing laboratory environment—meaning you’re learning with visibility into the kinds of validation and testing work that supports devices entering the market.
In practical terms: you’re not only learning “what the requirements are.”
You’re building the mindset of someone who understands how compliance is proven.
3) Career paths (and what this program prepares you to do)
Graduates commonly aim for roles such as:
- Regulatory Affairs Specialist / Manager
- Quality Assurance Specialist
- Compliance / Quality Systems roles
- Documentation, submissions, audit readiness, supplier quality support
Important note: no serious program should promise you a job. What matters is whether you leave able to perform at a higher level in the roles the industry needs.
This program is built to develop capability in areas that show up repeatedly in hiring—QMS, risk management, regulatory strategy, and documentation discipline—especially as QMSR and EU MDR expectations continue to shape the market.
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Ready to build the skills that regulated industries reward?
Download the full curriculum for the M.Sc. in Regulatory Affairs & Quality Assurance in Medical Technologies.