Top 5 In-Demand Roles for Diagnostics Success in 2026

Regulatory Affairs has become one of the most constrained functions in diagnostics. IVDR has increased the depth, volume, and complexity of regulatory work across the entire product lifecycle.

RA specialists with hands-on IVDR submission and lifecycle experience are essential for:

• Technical documentation and conformity assessments
• Managing notified body interactions
• Post-market surveillance and change control

The challenge is scale. Many manufacturers report that regulatory workload has grown faster than headcount, creating bottlenecks that delay launches and strain existing teams.

Market insight:

Across Benelux and DACH, IVDR-experienced RA specialists are among the slowest roles to fill. Time-to-hire regularly exceeds 6–9 months, and salary bands have risen sharply as companies compete for a limited pool of proven experts.

This role is no longer a back-office function. It directly determines market access and revenue timing.

As regulatory scrutiny increases, diagnostics companies are realising that quality leadership is a business-critical role, not just a compliance necessity.

Quality Systems Managers sit at the centre of:

• ISO 13485 implementation and maintenance
• Audit readiness and inspection management
• Post-market surveillance and CAPA processes
• Integration of quality into scale-up and manufacturing change

Under MDR and IVDR, administrative and documentation demands have grown significantly. Without strong quality leadership, organisations face audit findings, delayed approvals, and operational risk.

Market insight:

Many EU diagnostics manufacturers report quality resource constraints, particularly at management level. Weak quality leadership is a recurring factor in failed audits and prolonged remediation programmes, making experienced QMS managers highly sought after and difficult to replace.

Clinical evidence requirements for IVDs have increased, especially for higher-risk devices and novel technologies. This has pushed Clinical Studies Project Managers into a central role in diagnostics success.

These professionals are critical for:

• Planning and executing IVD clinical performance studies
• Coordinating CROs, sites, and internal teams
• Ensuring studies meet regulatory expectations under IVDR
• Supporting post-market clinical follow-up

The risk is delay. Without experienced clinical project leadership, evidence generation slows, pushing back submissions and market access.

Market insight:

Demand is rising for CPMs who understand both clinical operations and regulatory context. Companies report strong competition for candidates with IVD-specific experience, particularly those who have managed studies under IVDR timelines.

Diagnostics scale-up is no longer possible without automation. Cost pressure, volume growth, and quality expectations all point in the same direction: manufacturing must become more automated and more controlled.

Automation and Manufacturing Engineers play a key role in:

• Process validation and equipment qualification
• Line automation and robotics
• Yield optimisation and cost reduction
• Maintaining compliance during scale-up

The challenge is finding engineers who combine automation expertise with GMP and regulated manufacturing knowledge.

Market insight:

Across the EU, diagnostics companies are investing heavily in automation but struggle to hire engineers who understand both technology and compliance. Time-to-hire is long, and competition with pharma and advanced manufacturing sectors continues to push salaries upward.

Diagnostics is becoming data-centric. AI-enabled image analysis, algorithm-based IVDs, and multi-omics panels are reshaping how tests are developed and validated.

Data Scientists and Bioinformaticians are now essential for:

• Algorithm development and validation
• Image and signal analysis
• Integrating clinical, biological, and real-world data
• Supporting regulatory expectations for explainability and performance

This is not generic data science. Diagnostics requires professionals who understand regulated environments, validation, and clinical relevance.

Market insight:

Life sciences demand for AI and data talent is growing faster than average across Europe. Diagnostics companies compete not only with each other, but also with tech, health AI startups, and research institutes, making this one of the most competitive hiring areas going into 2026.

Across medtech and diagnostics, 84% of companies report that skills gaps already hurt performance, and most expect those gaps to widen. Regulatory, quality, clinical, manufacturing, and data roles sit at the centre of this challenge.

For HR leaders and site heads, several actions are becoming unavoidable:

• Prioritise these five roles early in workforce planning
• Accept that time-to-hire is longer and build timelines accordingly
• Invest in internal development where possible, but recognise limits
• Work with partners who understand IVDR, diagnostics operations, and local EU talent markets

Delaying decisions in these areas rarely saves cost. More often, it delays growth.

Across IVD and diagnostics, many companies know which roles they need, but underestimate how specialised the execution has become under IVDR. The difference between progress and delay often comes down to securing the right leadership profile at the right moment.

Here are a few recent, anonymised examples of how diagnostics organisations have approached these critical hires:

• Global Diagnostics Services Provider (EU IVDR Site, Netherlands): A multinational diagnostics testing organisation with a dedicated IVDR-regulated site required senior quality leadership to strengthen audit readiness and post-market processes. A QA / QMS Manager was appointed to stabilise the quality system under ISO 13485 and IVDR expectations, supporting both compliance and operational scale.

• International IVD Testing Organisation (Regulatory & Quality Leadership): An established diagnostics group operating across multiple EU markets needed integrated quality and regulatory oversight. A Manager QA/RA was hired to bridge regulatory submissions, quality systems, and notified body interactions, ensuring alignment across functions during IVDR transition.

• Mid-sized IVD Manufacturer (EU Market Expansion Phase): A growing diagnostics manufacturer entering new EU markets required hands-on regulatory expertise. An IVDR-focused Regulatory Affairs specialist was brought in to manage technical documentation, conformity assessments, and lifecycle updates, reducing submission risk and internal bottlenecks.

• Diagnostics Scale-Up (Clinical Evidence Generation): A company developing higher-risk IVDs strengthened its clinical function by hiring a Clinical Studies Project Manager with IVD-specific experience to manage performance studies, CRO coordination, and IVDR-aligned evidence generation.

• Advanced Diagnostics Manufacturer (Manufacturing & Automation): Facing increased production volumes, an EU-based diagnostics organisation appointed an Automation and Manufacturing Engineer with regulated manufacturing experience to support line automation, validation, and compliant scale-up.

Across all five cases, the common thread was not volume hiring; it was precision hiring for roles that directly influence regulatory timelines, audit outcomes, and market access.

The team here at Panda works exclusively in life sciences, diagnostics, and medtech. That focus allows us to understand not just job titles, but how roles function inside IVDR-regulated environments.

We support diagnostics organisations by:

• Mapping the talent market across Benelux, DACH, and the wider EU
• Identifying and engaging hard-to-reach RA, QA/QMS, clinical, automation, and data specialists
• Providing realistic salary benchmarks and time-to-hire expectations
• Advising on role scoping to avoid costly mis-hires under IVDR pressure

If you are reviewing your diagnostics hiring plan, or want to pressure-test where risk sits across regulatory, quality, or clinical functions, we are happy to share market insight or talk through what we are seeing across IVD organisations today.

Get in touch with our expert below:

Cristina Ruiz
IVD Recruitment Specialist | Panda International
📩 c.ruiz@panda-int.com | 🔗 https://www.panda-int.com/meet-the-team/cristina-ruiz/