
Over the past year, every sector has had to adapt to survive. While some industries have struggled, MedTech and Digital Health have thrived, unlocking opportunities for accelerated growth. Today, there are more connected devices than people on the planet. By 2025, analysts forecast more than 41 billion connected devices worldwide, each generating real-time data on how we live and work.
This explosion of data is not only transforming patient care, but also reshaping the regulatory and quality frameworks that companies must navigate. With the EU AI Act, MDR/IVDR requirements, and evolving guidance from regulators in the DACH region (Germany, Austria, Switzerland), compliance has become just as critical to success as innovation itself.
The Growth of the Digital Health Market in 2025
The global digital health market is projected to surpass $650 billion by 2025. But with growth comes heightened scrutiny. Across Germany, Austria, and Switzerland, hiring for regulatory affairs (RA) and quality assurance (QA) roles has risen sharply, alongside demand for technical specialists.
Employers are seeking professionals who can not only develop breakthrough MedTech solutions but also ensure alignment with ISO standards and the EU AI Act. Fast-growing start-ups in particular are under pressure to secure these skills as they race to scale while establishing the regulatory and quality foundations essential for long-term success.
Compliance Challenges: EU AI Act, MDR/IVDR, and ISO Standards
The regulatory landscape is evolving just as quickly as the technology itself:
Germany: Programs such as DiGA are accelerating the adoption of digital therapeutics, while authorities like BfArM and PEI increase their oversight of AI-enabled MedTech products.
Switzerland: Swissmedic is adapting MDR/IVDR pathways while building its own digital infrastructure.
Austria: Regulatory frameworks remain closely aligned with EU requirements.
For employers, this means more than just documentation—it demands specialists who can embed RA/QA compliance into every stage of product development.
RA/QA Hiring Trends in Germany, Austria, and Switzerland
As digital health apps, portable diagnostics, and connected platforms redefine the industry, the challenge is no longer just building innovative tools—it’s proving their safety, effectiveness, and compliance in real-world use.
This has driven demand for a new generation of professionals, including:
Regulatory affairs strategists
Quality assurance leads
Data governance experts
AI validation specialists
These skills are particularly sought after in the DACH MedTech market, where companies are scaling rapidly but face increasing pressure from regulators.
The Future of Regulatory Affairs and Quality in MedTech
At Medella Life, we see this shift first-hand. The MedTech and Digital Health industry in DACH is not just about innovation—it’s about building the regulatory and quality frameworks that sustain growth long term.
We connect visionary companies with the RA/QA talent they need to bring products to market—and keep them there—safely and sustainably, under the watchful eye of global regulators.
Need Expert Guidance?
If your organisation is scaling in MedTech or Digital Health and requires specialist advice or professional consultation on RA/QA hiring and compliance in the DACH region, reach out to our team at hello@medella.life.