The European health industry operates in an increasingly complex legislative landscape, where regulatory and quality requirements evolve as rapidly as healthcare innovations. To remain competitive, employers require professionals with expertise spanning market access, regulatory affairs, and quality management to safeguard product integrity and patient safety.
These competencies are essential to bring products swiftly and safely to the market. They directly influence commercial viability, investor confidence and company competitiveness.
Regulatory and quality excellence is a strategic differentiator in competitive international markets. Gaps in regulatory capability and quality management can result in delayed approvals, increased compliance costs, restricted market access and reputational exposure.
Compliance and regulatory competences are among employers’ top expectations according to labour market research conducted by the BRIGHTskills project. These skills are a workforce priority given companies’ dependence on timely regulatory approvals for market access and product uptake. However, companies - particularly SMEs -report persistent constraints linked to limited regulatory capacity, insufficient clinical evidence expertise and difficulties recruiting professionals capable of integrating QA/QC, GMP and risk management competences across product lifecycles.
Meanwhile, professionals working in this field report challenges in managing work-life balance and maintaining continuous professional development, both of which may be influenced by the rapidly evolving European regulatory context shaping product development and oversight requirements. As regulatory complexity increases, workforce planning must ensure that organisations define and develop competences in regulatory interpretation, clinical validation, quality management and lifecycle surveillance to meet compliance obligations.
To validate and prioritise the regulatory and quality competences required to ensure compliant and efficient market access for innovative health products in Europe.
This 1-hour online facilitated pan-European focus group will:
• A structured and prioritised regulatory and quality competence map supporting regulatory compliance, efficiency and market access.
• Practical recommendations for targeted regulatory and quality training programmes.
A Regulatory Excellence Framework designed to strengthen innovation capacity, compliance performance and competitiveness across the European health industry.
Participants will gain insight into shared regulatory and quality workforce challenges across the sector and emerging competence priorities linked to evolving EU frameworks.
By contributing operational and strategic perspectives, employers and professionals will directly shape the definition and prioritisation of regulatory and quality competences required to ensure compliant market entry and sustainable lifecycle management.
The resulting BRIGHTskills guidance will reflect business-led priorities and inform the development and format of training provision aligned with regulatory obligations, operational realities and long-term competitiveness objectives
