Beyond Compliance: AI in Medtech Regulatory Affairs
Artificial Intelligence (AI) has quickly become one of the hottest topics in MedTech. Today’s conversation focuses on efficiency — faster drafting of regulatory submissions, streamlined document management, and reducing the administrative burden. These are all essential benefits, but they only scratch the surface of what AI can do. If we stop at efficiency, we risk underselling the true potential. AI is not just a tool for compliance; it can redefine regulatory affairs as a strategic driver of growth and innovation in MedTech.
From Incremental Gains to Strategic Transformation
Recent publications from BCG, Indegene, and Veeva highlight clear opportunities for AI to support regulatory teams:
- Automating first drafts of regulatory documentation, cutting writing times by as much as 60–70%.- Summarizing regulations, extracting key entities, and supporting health authority query responses.
- Managing interdependencies across multiple regulatory submissions for different markets.
These are all valuable. But they largely frame AI as a productivity booster. What’s missing is the recognition that regulatory affairs can evolve from being a “compliance checkpoint” to a strategic enabler of market access and innovation. AI as a Market Access Accelerator. In MedTech, time-to-market is everything. Delays in regulatory approvals not only slow growth but can also impact patient access to life-saving technologies.
Here’s where AI can change the game: Predictive intelligence: Instead of simply reacting to regulatory requirements, AI can monitor and analyze evolving guidelines across geographies, forecasting potential changes before they happen.
Risk anticipation: AI-driven analytics can flag compliance risks early in the product lifecycle, allowing design or documentation adjustments before submission bottlenecks occur.
Global harmonization: AI can help companies align submissions across the EU, UK, Switzerland, FDA, and beyond, reducing duplication and ensuring consistency in strategy.
This isn’t just about getting approvals faster — it’s about giving MedTech companies the confidence to expand into new markets proactively, with regulatory affairs leading the charge.
From Compliance Officers to Strategic Advisors. The traditional view of regulatory affairs professionals is that of gatekeepers — ensuring documents are complete, accurate, and submitted on time. With AI taking on much of the “heavy lifting” (drafting, summarization, data cross-checking), RA professionals can step into a new role: strategic advisors to the business.
This shift means RA teams can:
Advise leadership on the best regulatory pathways to accelerate market entry.
Guide R&D in designing products that meet today’s and tomorrow’s requirements.
Support commercial teams in planning global expansion strategies with regulatory foresight.
In this model, regulatory affairs becomes less about saying “no” or slowing things down — and more about driving more intelligent, faster decisions across the organization.
Balancing Innovation with Governance
Of course, AI in regulatory affairs must be handled carefully. Both Indegene and Veeva emphasize the importance of guardrails:
Human-in-the-loop validation to ensure accuracy and prevent “AI hallucinations.”
Data privacy and security are paramount given the sensitive nature of regulatory and patient information.
Transparent processes so that regulators themselves can trust the AI-augmented outputs they receive.
The future is not “AI replacing RA professionals,” but rather AI augmenting human expertise — creating more time for judgment, strategy, and decision-making where it matters most.
A Call to Action for MedTech Leaders
The MedTech industry is at an inflection point. AI is already proving its value in efficiency, but the real opportunity lies in something bigger:
Elevating regulatory affairs from compliance management to strategic leadership.
AI is used not only to do things faster but also to do them smarter, better, and with foresight. Repositioning RA teams as a core market access, innovation, and growth driver. In an innovation-defined industry, we stop treating regulatory affairs as a back-office function and start recognizing it as a strategic powerhouse. With AI as the catalyst, the regulatory function of the future won’t just ensure compliance — it will shape the future of MedTech itself.
Benjamin Arazy, Arazy Group
