This blog explores whether certifications like the RAC or ISO 13485 certified quality auditor (CQA) are necessary to succeed in regulatory affairs. It breaks down which certifications matter, when to pursue them, and why practical experience and foundational knowledge are more important early in your career.
Certifications in Regulatory Affairs
Certifications can enhance a regulatory affairs career, but their value depends on when and why they’re pursued. We help early-career professionals understand which certifications matter, when to pursue them, and what to focus on instead at the start of their journey.
Certification Value
• RAC Certification: Highly respected, especially at mid-to-senior levels. Best pursued after gaining hands-on regulatory experience.
• ISO 13485 Auditor: Ideal for those involved in quality systems or audits in Med Tech environments.
• GCP & CQA Certifications: Useful for those working near clinical or QA functions but not essential early on.
• Early-Stage Focus: Certifications are rarely required for entry-level roles. Employers value foundational knowledge and initiative more.
Foundation Over Formalities
New professionals often assume certifications are mandatory to land a job, which can lead to unnecessary pressure, costs, and delays in building real-world skills. This misalignment creates a gap between what employers expect and what candidates invest in early on.
Entry-Level Strategy
To grow a successful regulatory career, especially in its early stages, professionals should prioritize:
• Practical understanding of regulatory frameworks
• Strong communication and documentation skills
• Hands-on project exposure through internships or related roles
• Community support and mentorship from experienced professionals
Guided Learning & Career Readiness
At Regulatory Academy, we help you start smart — with content, guidance, and community access tailored for early-stage professionals. Instead of overwhelming you with advanced certifications too soon, we provide the tools, clarity, and confidence to build your career the right way.
Join Our Community
We simplify complex choices like certifications by guiding you with honest, experience-based insights. You’ll always know where you stand and what your next step should be. Through our growing SKOOL community, expert content, and job-focused insights, we make sure you’re never navigating your career alone.