Introducing SARA – Society for AI in Regulatory Affairs

Team Hoodin
Jul 10
3 min read

Updated: Jul 13

If you work in Regulatory Affairs today, you have probably already been asked: "Where should we use AI?" or perhaps even, "Why aren't we using it yet?"

Over the past year, AI has shifted from a future vision to a present reality for many regulatory teams. Some organisations have already integrated the technology into parts of their work. Others are still evaluating where it best fits. Some remain sceptical, while others see AI as the biggest opportunity the profession has experienced in decades.

What is striking is not that opinions differ.

What is striking is that everyone is trying to answer essentially the same questions.

Where does AI actually create value?

Where are the risks?

What does responsible use look like in a regulated environment?

How will the role of the regulatory professional change over the next five or ten years?

Those questions deserve better than headlines, product demonstrations and LinkedIn debates.

That is why Hoodin and CertHub have come together to found SARA – Society for AI in Regulatory Affairs, in partnership with MedTech Leading Voice.

Why this collaboration? Because together, Hoodin, CertHub and MedTech Leading Voice bring a rare combination of practical experience and theoretical expertise in both AI and Regulatory Affairs. Between us, we have implemented AI in complex organisations, built regulatory systems and processes from the ground up, and closely followed the evolving regulatory landscape, including the EU AI Act. We are neither naïve technology optimists nor fearful traditionalists. We are practitioners who understand what it takes to make technology, quality and regulatory compliance work in practice.

SARA is not intended to promote artificial intelligence. Nor is it intended to argue against it.

Our starting point is much simpler. AI is becoming part of Regulatory Affairs, whether organisations are ready or not. The profession therefore needs a place where the technology can be discussed openly, critically and from different perspectives.

That means talking about the opportunities AI creates, but also the limitations, risks and responsibilities that follow. Productivity gains are interesting, but so are governance, validation, human oversight, traceability and organisational readiness.

The discussion should not be driven by hype. Neither should it be driven by fear. It should be driven by experience.

"One of the reasons for creating SARA is that none of us yet has enough experience to define what good AI-supported Regulatory Affairs looks like. The technology is evolving faster than the profession's collective experience of using it.

We see real value in creating a place where organisations can openly share practical experience, challenge each other's assumptions and collectively improve the profession's understanding of where it is heading. As the organisations behind this initiative, together with MedTech Leading Voice, we intend not only to participate in that conversation but to facilitate it and help shape it."

— Marcus Emne, CEO, Hoodin

SARA will bring together people with different backgrounds and different opinions:

Regulatory professionals
Quality professionals
Technology companies
Consultants
Certification experts
Former regulators
Academics

Not because they are expected to agree, but because no single perspective is sufficient to understand how AI will reshape Regulatory Affairs.

The initiative will consist of webinars, round tables, articles, interviews and ongoing discussions where practical experience is valued at least as highly as theory.

"AI will become part of Regulatory Affairs, but successful adoption is not about implementing another tool. It is about understanding where AI adds value, where it does not, and how it can be introduced without compromising quality, compliance or confidence. Those conversations need to happen across the industry, not only inside individual organisations."

— Leon Kobinger, Co-Founder & CEO, CertHub

MedTech Leading Voice joined the initiative as a strategic partner because building a stronger profession requires more than technology. It requires a place where people are willing to share experience, discuss difficult questions and learn from one another.

"The learning curve in regulatory affairs is steep, and we're all facing it at once. Community is the real moat. Pooling our knowledge and learning together is the only thing that carries us through. Going it alone is nearly impossible."

— Sean Smith, Founder, MedTech Leading Voice

Do you want to be part of this from the start?

Whether you are curious, sceptical or already on your AI journey, your perspective is welcome.

Join SARA from the very beginning

Whether you are curious, sceptical or already on your AI journey, your perspective is welcome.

Join SARA to receive our newsletter, invitations to webinars and round tables, early access to new content, and opportunities to participate in future discussions and initiatives.

Whether you simply want to stay informed or actively contribute as a participant or speaker, you are welcome.

Together, we can build the knowledge base our industry so badly needs.

Join SARA