GLOBAL REGULATORY AFFAIRS WORKFORCE REPORT 2024

Global Regulatory Affairs Workforce Report 2024

Media Contacts:

Ryan Connors

Regulatory Affairs Professionals Society (RAPS)

rconnors@raps.org 

+ 1 (301) 770-2920, ext. 234

 

Jessica Price

Elemed

jessica@elemed.eu 

+41 21539 1933

 

 

 

New Report Showcases a Global Regulatory Affairs Workforce 

of Nearly 125,000 Professionals Across the Healthcare Products Sector

 

Rockville, Md., April 30, 2024 — The second edition of a joint report released today from RAPS and Elemed, a total talent management agency specializing in regulatory affairs, highlights that nearly 125,000 professionals around the world currently work in the field of regulatory affairs for healthcare products such as pharmaceuticals, medical devices, and biotechnology products. 

 

The 2024 Global Regulatory Affairs Professionals Workforce report provides a snapshot of the size and health of the regulatory affairs profession, detailing vital field statistics such as the number of regulatory professionals by region, sector, role, job level, educational background, tenure and “open to work.” The report also offers insights into key location hubs, major employers, professional challenges, and DEI+B concerns — providing trends and comparisons to the original data released in 2021.

 

“This report has been transformative in understanding the landscape and demographics of the global regulatory workforce,” said RAPS Executive Director Bill McMoil. “Having these insights allows RAPS to develop new programs and serve our members, and the global regulatory community at-large, more effectively and efficiently.”

 

The field of regulatory affairs encompasses a global network of professionals situated in major regions and hubs worldwide. Collectively, the six major regions detailed in the report — Africa, Asia, Europe, Latin America and the Caribbean, North America, and Oceania — comprise a total of 124,436 regulatory affairs professionals. 

 

“Life-saving healthcare products, whether created by innovative and agile startups or global manufacturing giants, rely on talented regulatory experts to bring them to patients whilst guaranteeing their safety and efficacy,” emphasized Elena Kyriacou, the Founder and CEO of Elemed, headquartered in Zürich. “This report underscores the global demand for regulatory proficiency, highlighting its indispensable role around the world.”

 

Data in the report was obtained from LinkedIn.com — an online business networking platform with a reported coverage of 1 billion professionals across over 200 countries — and analyzed and segmented by region and sub-region as classified by the United Nations Statistics Division (UNSD). Subregion Showcases delve deeper into key Europe countries, US regions, Canadian provinces, Brazil, India, and South Korea.

 

Key data points from the 2024 Global Regulatory Affairs Professionals Workforce report include:

 

  • There are 124,436 regulatory professionals around the world.

  • The highest concentration of regulatory professionals is in Europe with 45,201, followed by North America with 34,473, and Asia with 31,961.

  • There are 31,133 regulatory professionals in the US alone.

  • Globally, the regulatory affairs industry continues to be predominantly concentrated in the pharmaceutical category, comprising approximately 70% of all professionals, representing a 5-point increase compared to 2021 findings (65%). 

  • 21% of professionals work in the medical devices sector, while just under 9% are employed in biotechnology.

  • The share of employees seeking new work opportunities has increased globally from 15% in 2021 to 25% in 2024 (+10 pts).

  • The percentage of regulatory affairs professionals who have been in their current roles for two years or fewer ranges from about 40% in Africa (an increase of 2 points since 2021) to 52% in Latin America and the Caribbean (a decrease of 1 point since 2021).

  • The percentage of professionals working for large companies, with 5,000 or more staff, varies from a low of 34% in Africa (a decrease of 6 points since 2021) to a high of 54% in Latin America and the Caribbean (a decrease of 11 points since 2021). These statistics may reflect a diversification of organization sizes resulting from industry growth.

 

The 2024 Global Regulatory Affairs Professionals Workforce report is available for free and can be downloaded at www.raps.org/2024WorkforceReport.

 

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About Elemed

Elemed is a boutique talent management company that transforms lives by recruiting talent to solve regulatory problems, helping to provide healthcare products to patients all over the world. Elemed assists medical device and IVD companies of all sizes to achieve their business goals by attracting, hiring, and retaining exceptional regulatory talent. Elemed has a longstanding relationship with RAPS, collaborating on projects to raise awareness of and further advance the regulatory affairs profession. A recent joint venture has been the Elemed Mentoring Academy, which is just one of many ways Elemed activates potential and unlocks pathways for the regulatory experts of today and the leaders of tomorrow. Through the Elemed network, companies can access exceptional candidates, valuable data insights, salary surveys, talent trends, and knowledge on how to build a diverse global workforce of the future. For more information, please visit www.elemed.eu

 

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide. For more information, visit www.RAPS.org.

medtech skills

The Seven Hottest MedTech Skills

Innovating Healthcare: The Seven Hottest MedTech Skills Right Now

In the ever-evolving landscape of healthcare, the fusion of various MedTech skills and disciplines plays a pivotal role in driving innovation, particularly in the realm of medical devices and diagnostics. From harnessing data science, digital health, and AI to ensuring cybersecurity and integrating disciplines like CDx (Companion Diagnostics), sustainability, microbiology, toxicology, sterilisation, materials engineering, and data governance, MedTech is undergoing a transformative journey. 

Read on for the seven hottest skills that are shaping the future of healthcare.

1. Data Science, Digital Health, and AI: Transforming Healthcare Delivery

Innovations in data science, digital health, and AI are revolutionising how healthcare is delivered, enabling personalised care, predictive analytics, and real-time monitoring. Here’s how they synergise in MedTech:

– Data-driven insights allow for tailored treatment plans and medical interventions based on individual patient data, leading to better outcomes

– AI algorithms analyse vast datasets to predict disease trends and patient outcomes, and optimise treatment strategies, enhancing clinical decision-making

– Digital health technologies enable remote monitoring of patients’ health parameters, facilitating timely interventions and reducing hospital readmissions

2. Cybersecurity: Safeguarding Sensitive Health Information

As healthcare becomes increasingly digitised, cybersecurity becomes paramount to protect patient data and medical devices from cyber threats. In MedTech, cybersecurity measures ensure:

– Sensitive health data is encrypted to prevent unauthorised access and maintain patient privacy

– Regular assessments and updates are conducted to address vulnerabilities in medical devices and software, safeguarding against cyberattacks

– Adherence to data protection regulations such as HIPAA and GDPR ensures the secure handling of patient information.

3. Companion Diagnostics (CDx): Advancing Precision Medicine

CDx plays a crucial role in precision medicine, enabling the selection of targeted therapies based on patients’ genetic profiles and disease characteristics. In MedTech, CDx offers:

– Companion diagnostics identify biomarkers that predict a patient’s response to specific therapies, optimising treatment efficacy and minimising adverse effects

Adherence to data protection regulations such as HIPAA and GDPR ensures the secure handling of patient information

4. Sustainability: Promoting Eco-Friendly Practices in Healthcare

Incorporating sustainable practices in MedTech not only reduces environmental impact but also enhances operational efficiency and cost-effectiveness. Sustainable initiatives in MedTech include:

– Utilising eco-friendly materials and manufacturing processes to minimise waste generation and energy consumption

Implementing strategies for product reuse, recycling, and disposal to reduce environmental footprint and promote circular economy principles

5. Microbiology and Toxicology: Ensuring Product Safety and Efficacy

Microbiology and toxicology play critical roles in assessing the safety and efficacy of medical devices and diagnostics, ensuring compliance with regulatory standards. In MedTech, these disciplines involve:

– Evaluating the compatibility of medical devices with biological systems to ensure patient safety and minimise risks of adverse reactions

Assessing the potential toxicity of materials used in medical devices and diagnostics to mitigate health hazards and ensure product quality

6. Sterilisation and Materials Engineering: Enhancing Product Reliability

Sterilisation and materials engineering are integral to the design and manufacturing of medical devices, ensuring product reliability and patient safety. In MedTech, these disciplines focus on:

– Implementing effective sterilisation techniques to eliminate microbial contamination and maintain product sterility throughout its lifecycle

Choosing biocompatible and durable materials for medical device construction to withstand sterilisation processes and ensure long-term performance

7. Data Governance: Ensuring Ethical and Responsible Data Management

Data governance frameworks establish policies and procedures for ethical and responsible data management, promoting transparency, integrity, and accountability. In MedTech, data governance entails:

– Ensuring patient consent and adherence to data privacy regulations to protect sensitive health information from unauthorised access or misuse

Implementing measures to maintain data accuracy, completeness, and reliability, enhancing the trustworthiness and usability of healthcare data

Conclusion: Shaping the Future of MedTech through Collaboration and Innovation

The convergence of diverse skills and disciplines in MedTech represents a collaborative effort to address healthcare challenges and improve patient outcomes. By harnessing the power of data science, digital health, AI, cybersecurity, CDx, sustainability, microbiology, toxicology, sterilisation, materials engineering, and data governance, stakeholders in the healthcare ecosystem can drive meaningful advancements and shape a more sustainable, efficient, and equitable future for healthcare delivery. As we continue to embrace innovation and collaboration, we should remain committed to leveraging technology responsibly to transform healthcare for the better.

As the healthcare landscape continues to evolve, the demand for these skills will only intensify. Professionals who possess expertise in these areas will be at the forefront of driving innovation and shaping the future of healthcare. Whether you’re a data scientist, cybersecurity expert, materials engineer, healthcare provider or device manufacturer, staying abreast of these trends and honing these in-demand skills will be essential for success in the dynamic field of MedTech. Learn more about how elemed supports finding exceptional talent across these specialisms through total talent management