Europe’s health industry is entering a period of regulatory and technological change. Artificial intelligence, network-connected medical devices that exchange patient or performance data, personalised medicine, biotechnology and health-data use are reshaping how products are researched, developed, manufactured and monitored. Organisations must also operate within frameworks intended to protect patients, ensure quality and enable trustworthy innovation1,2.
Regulation is therefore more than a final compliance check. It influences decisions throughout the product lifecycle—from research and clinical development to manufacturing, market access, post-market surveillance and supply-chain management. Regulatory science is multidisciplinary, bringing together scientific evidence, law, public health and business considerations to ensure that regulated products are safe, effective and of appropriate quality3.
A complex and evolving landscape
Different parts of the health industry must navigate increasingly connected requirements. Pharmaceutical and biomanufacturing organisations work within rules covering clinical trials, marketing authorisation, good manufacturing practice, pharmacovigilance and security of supply. In December 2025, the EU institutions reached a political agreement on reforming the Union’s pharmaceutical legislation, aiming to improve access to medicines, support innovation, streamline procedures and strengthen the management of shortages.
Medical-device and diagnostic companies operate under the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. These frameworks reinforce requirements related to conformity assessment, evidence, traceability and post-market activities. Regulatory infrastructure is also becoming more digital. Since 28 May 2026, four EUDAMED modules have been mandatory: actor registration; UDI and device registration; notified bodies and certificates; and market surveillance. EUDAMED is intended to support transparency and coordination across the EU4,5.
Implementation nevertheless requires considerable organisational capacity. European health ministers and medical organisations have raised concerns about supply disruption, certification bottlenecks and the burden faced by smaller manufacturers. A 2024 MedTech Europe survey of 73 IVD and 138 medical-device manufacturer organisations found that securing qualified regulatory-affairs employees was difficult for 86% of large and 91% of SME medical-device respondents. These results do not represent the entire European labour market, however, they indicate the recruitment challenges and pressure among participating manufacturers6.
Digital health adds further layers. Software may qualify as a medical device, while certain AI systems may be classified as high-risk under the EU AI Act. Developers may therefore need to connect product regulation with AI governance, quality management, data protection and cybersecurity. The European Health Data Space establishes a common framework for exchanging electronic health data and enabling its secure reuse in research, innovation, policymaking and regulatory activities. Its obligations will apply progressively from 20295.
Why regulation is a skills issue
As these frameworks overlap, regulatory knowledge cannot remain only within specialist teams. Researchers, engineers, clinicians, data scientists, quality managers, manufacturing professionals, entrepreneurs and leaders all make decisions that can affect safety, evidence generation, compliance and market readiness. Regulatory science therefore depends on professionals who can work across scientific, legal, technical and organisational boundaries.
The skills required are also broadening. Alongside knowledge of legislation, standards and submissions, professionals increasingly need regulatory intelligence, risk-based decision-making, data literacy and familiarity with digital systems. Communication, project management, critical thinking and cross-functional collaboration are equally important because complex scientific and legal requirements must be translated into clear actions for research, clinical, quality, manufacturing and commercial teams. Industry career guidance also highlights AI, software as a medical device, regulatory information management systems and data integrity as growing knowledge areas7.
The profession’s scale is significant. The 2024 Global Regulatory Affairs Professionals (RAPS) Workforce report identified nearly 125,000 regulatory-affairs professionals worldwide, including 45,201 in Europe. Yet, the headcount alone does not ensure access to the necessary combination of scientific, digital, strategic and interpersonal competencies. RAPS commentary has also highlighted the value of more structured training and certification, particularly because many professionals enter regulatory affairs from adjacent disciplines8,9.
How BRIGHTskills is responding
BRIGHTskills supports Europe’s pharmaceutical and biomanufacturing, MedTech, digital-health and medical-supply industries by connecting skills intelligence with practical learning. Its stackable continuing professional development courses are informed by employers’ workforce needs and cover AI and digital skills, regulation, operations, supply chain and quality management, entrepreneurship and leadership, and sustainability.
This integrated approach reflects how regulatory challenges arise in practice. An AI-enabled diagnostic product, for example, may require expertise in software development, clinical evidence, quality systems, data governance, cybersecurity and regulatory strategy. Professionals must understand how their responsibilities connect with those of colleagues across the organisation. The ability to translate regulatory requirements into coordinated action is therefore as important as knowledge of the rules themselves.
The BRIGHTskills course Strategically Navigating the Regulatory Landscape led by the University for Continuing Education Krems responds directly to this need. It provides a comparative introduction to European and US laws, guidelines and standards affecting the development and commercialisation of healthcare products.
Towards a regulation-ready workforce
Europe’s regulatory landscape will continue to evolve alongside science, technology and public expectations. Keeping pace requires more than monitoring new rules: organisations need people who can interpret requirements, anticipate operational effects and embed them into responsible decisions.
By combining employer-informed skills intelligence with flexible, competency-based training, BRIGHTskills supports a shift from reactive compliance towards proactive regulatory capability. Strengthening these skills can help organisations protect patients, build trust and bring high-quality innovation to market more confidently—contributing to a more resilient and competitive European health industry.
Ready to strengthen your regulatory capabilities?
Explore the BRIGHTskills training courses to find learning opportunities aligned with the evolving needs of the health industry. You can also use the BRIGHTskills self-assessment tool to reflect on your current competencies, identify possible skills gaps and discover areas for further professional development.
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