Navigating Global Regulatory Shifts: Preparing Diagnostic Teams for the Next Compliance Wave

In the diagnostics industry, regulation isn’t a hurdle - it’s the backbone of trust. Yet as global regulatory frameworks evolve rapidly, teams that once operated with stable compliance roadmaps now face shifting goalposts. The introduction of the EU's MDR (Medical Device Regulation), IVDR (In Vitro Diagnostic Regulation), and ongoing FDA guideline changes is transforming how diagnostic companies must think about talent, training, and collaboration.

For diagnostics teams, success in this environment doesn’t just depend on scientific accuracy, it hinges on regulatory agility too. To achieve that perfectly, organisations need a forward-looking people strategy.

The Regulatory Shift: What’s Happening?

Europe: The MDR & IVDR Landscape

The EU MDR (fully applicable since May 2021) and IVDR (phased implementation through 2028) represent a seismic change in how devices and diagnostics are assessed. IVDR in particular has brought:

• Stricter classification of diagnostic devices (most IVDs now require third-party assessment)
• Increased demand for clinical evidence and performance data
• A greater emphasis on post-market surveillance and vigilance
• Significant bottlenecks in Notified Body capacity

These regulations aim to ensure better patient safety and traceability - but they’ve also placed heavy pressure on regulatory, clinical, and quality teams.

United States: FDA Modernisation and Digital Oversight

Meanwhile, the FDA continues to evolve its approach:

• Implementing more guidance around software as a medical device (SaMD)
• Tightening real-world evidence and post-market reporting expectations
• Increasing scrutiny on lab-developed tests (LDTs) and AI-powered diagnostics

Combined, these changes are driving a new era of compliance, one that demands not just technical capability, but strategic foresight and cross-functional fluency.

What This Means for Talent Strategy

Navigating these shifts requires more than adding headcount. It requires reshaping who you hire, how you train, and how teams work together.

1. Proactive Regulatory Hiring

The demand for experienced regulatory professionals is skyrocketing, particularly those who:

• Have direct IVDR submission experience
• Understand FDA’s digital diagnostic frameworks
• Can build scalable regulatory strategies across global markets

Unfortunately, this is a candidate-short market. The companies succeeding are those who:

• Seek and engage with passive candidates early
• Offer hybrid or remote flexibility to widen the talent pool
• Partner with specialist recruiters who understand the nuance of diagnostics regulation & have access to a deep network of professionals

2. Cross-Training as a Competitive Edge

IVDR and MDR have blurred traditional role boundaries. Clinical affairs teams now need to understand regulatory classification. Quality professionals need insight into post-market requirements. Software engineers need to speak the language of FDA auditors.

Progressive organisations are responding by:

• Implementing cross-training programs between clinical, quality, and regulatory teams
• Embedding regulatory expertise into product development - not just post-development
• Encouraging interdisciplinary hiring to bring diverse lenses into compliance strategy

This cross-functional understanding leads to smoother submissions, faster iteration, and fewer regulatory surprises leading to disruption.

3. Investing in Regulatory Intelligence Roles

With guidance shifting regularly, companies are increasingly hiring or upskilling for Regulatory Intelligence Specialist professionals, who:

• Track and interpret global regulation updates
• Advise on strategic implications for pipeline and portfolio planning
• Feed updates into risk registers and compliance roadmaps

These roles act as navigators, ensuring the company isn’t just compliant today, but looking forward and prepared for what’s next.

Training for the Next Compliance Wave

Even the best hires can’t keep up without ongoing support. Companies now need structured learning programs that go beyond onboarding. This includes:

• Regular compliance briefings on IVDR/FDA changes
• Workshops on risk-based documentation and real-world evidence
• Scenario training to prepare teams for audits and inspections

The diagnostic companies thriving in this regulatory era are those where learning is embedded, not optional.

From Siloed to Integrated

In summary, compliance success today doesn’t come from isolated excellence, it comes from team integration. That means breaking silos between:

• R&D and regulatory
• Software development and QA
• Clinical and commercial teams

The best-in-class companies are:

• Creating cross-functional pods for product development
• Involving regulatory teams earlier in the innovation cycle
• Appointing compliance champions in non-regulatory roles

Not only reducing risk - but accelerating product timelines and aligning everyone behind shared goals.

 

Make Regulatory Change a Talent Opportunity

The global compliance landscape is complex, but remains an opportunity to build smarter, more agile, and more aligned teams. In diagnostics, where precision and trust are non-negotiable, the strength of your talent strategy may soon be as important as the strength of your science.

At HRS, we partner with diagnostics companies across the globe to:

• Identify future-focused regulatory and quality leaders
• Build cross-trained, compliance-ready teams
• Navigate hiring in a highly competitive, evolving landscape

In the next compliance wave, it won’t just be the most innovative teams that win – it will be the most prepared.