How to Build a Compliance Ready QA/RA Team under IVDR

IVDR at a Glance: New Demands on Diagnostics

The IVDR (EU 2017/746) represents a seismic shift in how in vitro diagnostics are regulated in Europe. Under the previous IVDD, only about 20% of IVD devices required Notified Body oversight, but under IVDR, 80–90% will need Notified Body assessment. This means far more audits, technical documentation reviews, and ongoing compliance work for QA/RA teams. Key changes include stricter classification rules, mandatory quality management system (QMS) requirements, and robust clinical evidence obligations.

The IVDR took full effect in May 2022 for new products, but transitional periods for legacy devices now stretch to 2025–2029 (depending on class) to avert market shortages. For example, legacy Class D devices have until Dec 2027, Class C until Dec 2028, and Class B and A (sterile) until Dec 2029 to fully comply. However, don’t be complacent; manufacturers must have an IVDR-compliant QMS by May 26, 2025, and apply to a Notified Body by key deadlines. In other words, the clock is ticking for your QA/RA team to get everything in place well before those final dates.

IVDR’s heightened scrutiny means QA/RA professionals truly sit “at the heart of every successful product”, as one industry analysis noted. They ensure that innovation doesn’t hit regulatory roadblocks and that patient safety is never just a checkbox. Under IVDR, QA/RA teams must handle tasks like: preparing extensive technical documentation, updating QMS processes to meet ISO 13485 and IVDR Part A/Annex IX requirements, conducting or reviewing clinical performance studies, and liaising with Notified Bodies during audits and conformity assessments.

The stakes are high. A single gap in compliance can lead to certification delays, market withdrawals, or costly recalls. Regulatory Affairs managers need to navigate new classification rules and guide products through multi-step conformity assessments. QA specialists must embed a culture of audit-readiness. Notified Bodies will audit QMS and technical files at least annually to ensure ongoing compliance. With IVDR’s complexity, it’s clear that building a capable team is the only way to stay on top of requirements and deadlines.

To be IVDR-ready, you need more than generalists – you need the right specialists in key QA/RA roles. Here are the core players and competencies for a diagnostics compliance team:

Essential Regulatory Affairs Roles (RA)

• Regulatory Affairs Manager / Specialist:
  Your RA lead will be the architect of the IVDR compliance strategy. They must deeply
  understand EU regulations and guidance (MDR/IVDR, MEDDEV, MDCG guidance) and know how to classify devices, compile technical documentation, and handle submissions. RA specialists will manage interactions with Notified Bodies and Competent Authorities. Experience with ISO 13485 QMS and prior MDR or IVDR submission experience is gold.
  
  According to a 2023 industry survey, 56% of medtech companies have fewer than 10 RA staff on average, so if you’re a smaller firm, one RA manager may wear many hats. Ensure they have training on IVDR Annexes, risk management (ISO 14971), and are adept at regulatory intelligence (staying ahead of rule changes).
  
  
• Clinical Affairs / Performance Evaluation Expert:
  Under IVDR, clinical evidence is critical. If you have any novel or high-risk IVDs, consider a clinical affairs specialist or scientist who designs studies and gathers performance data. They will work closely with RA to produce the Performance Evaluation Report (PER) and coordinate any required clinical performance studies or post-market performance follow-up (PMPF). This role may also liaise with labs or external partners for studies. Strong knowledge of IVDR Annex XIII (performance evaluation) and stats or data analysis skills are a plus.
  
  
• Person Responsible for Regulatory Compliance (PRRC):
  The IVDR mandates that manufacturers have at least one PRRC, essentially an internal QA/RA expert accountable for compliance. This might be fulfilled by your RA Manager or QA Manager if they meet the qualification requirements (e.g., 4+ years RA/QA experience in IVDs with relevant education). The PRRC oversees regulatory conformity and post-market surveillance. Make sure someone on the team is designated for this responsibility and stays up-to-date with IVDR Article 15 requirements.

Quality Assurance Manager / Quality Systems Lead:
QA leaders ensure your Quality Management System is IVDR-compliant and efficient. They drive updates to SOPs, documentation practices, supplier controls, and training so that every process meets IVDR and ISO 13485 standards. Key skills include audit management (internal and external), risk management, and document control. Since 69% of QA leaders doubt their current QMS can scale for growth (many still rely on paper or spreadsheets), a QA manager who can implement eQMS tools or more robust document control is invaluable. They also cultivate a culture of quality: “audit-ready every day” is the mindset your QA team needs under IVDR’s regimen of annual Notified Body audits.

Design Quality and Validation Engineers:
These team members work cross-functionally with R&D and manufacturing to ensure product design controls, verification/validation (V&V), and production processes meet quality requirements. They make sure risk management files (ISO 14971) are maintained and that any design changes trigger the necessary regulatory reviews. For example, if a software update changes an assay’s performance, the quality engineer ensures it goes through proper validation and regulatory notification if needed. Strong detail orientation and familiarity with technical documentation are a must.

Post-Market Surveillance (PMS) and Vigilance Specialist:
IVDR imposes rigorous PMS and vigilance duties, trend reporting, periodic safety update reports (PSURs), vigilance reporting of incidents, etc. If you have a broad product portfolio, dedicating a QA/RA team member to post-market data collection and analysis is wise. They will work on customer feedback, complaint trending, and field safety corrective actions, feeding this data back into risk management and regulatory reporting. This role’s analytical skills help catch issues early and keep you in good standing with both Notified Bodies and regulatory authorities.

Soft skills across these roles matter too. Communication and collaboration are vital when QA/RA professionals must mediate between engineers, scientists, and auditors. Attention to detail can’t be overstated – even minor errors can cause major compliance failures. Look for team members who are proactive, meticulous, and calm under audit pressure.

Finding talent with the right mix of regulatory knowledge and industry savvy is easier said than done – especially in today’s competitive market. A recent report showed 84% of medtech companies face talent shortages in specialised roles like regulatory and quality, and 90% struggle to hire enough RA experts. Here’s how to overcome these challenges:

Upskill Your Existing Talent vs. Hiring New Specialists

Start by assessing your current team’s capabilities. Identify gaps:
Do you lack IVDR regulatory expertise? Clinical affairs experience? If you have promising internal candidates, consider upskilling them. Training programs on IVDR (e.g. IVDR foundations, ISO 13485 lead auditor courses, or RAC certifications) can rapidly elevate a junior QA or RA staff into a more senior role. Investing in your people not only fills skill gaps but also boosts retention. (Plus, internal employees already know your product and culture.)

However, training takes time, and IVDR deadlines are approaching. As Robyn Meurant, a leading IVDR expert, put it: “With the IVDR fast approaching, it’s imperative for success to have the right people in the right job right now.” If you don’t have the luxury of time or your team is too stretched, it’s time to hire externally.

When hiring new talent, prioritise IVDR experience. Professionals who have worked with EU MDR can often cross over to IVDR with ease, given the similar structure and rigour. In fact, one strategy is to hire experienced RA people from the medical devices sector (MDR experts) and train them on IVD specifics; they’re already seasoned in navigating EU regulations. Also consider candidates from related disciplines: an internal R&D scientist or quality engineer with deep IVD product knowledge could be transitioned into a regulatory or compliance role with training. They bring invaluable product-specific insight to the team.

Because QA/RA talent is in short supply, you might need to cast a wider net and be creative:

1.  Engage specialised recruiters or agencies:
   Don’t hesitate to partner with a recruitment firm that focuses on MedTech and diagnostics hiring. A good specialist recruiter already has a network of IVDR-savvy candidates (active and passive) and can save you months of searching. They also understand the nuances of regulatory roles, ensuring you don’t waste time on the wrong candidates. As one industry recruiter observed, “Roles that once filled in 45–60 days now take 6+ months [to fill]. There’s a shortage of candidates with...global expertise and clinical understanding. Companies must start hiring earlier, consider adjacent skills, and strengthen their employer branding. Regulatory talent wants purpose, not just a paycheck.” In short, be proactive and sell your mission to attract the best people.
   
   
2. Use interim experts or consultants:
   If a permanent hire isn’t feasible quickly, consider bringing in an IVDR consultant or interim QA/RA contractor. An experienced contractor can establish processes, prepare documentation, and even train your team on the job. This ensures compliance tasks keep moving while you search for the right long-term hire. Just be sure to integrate contractors with your team so knowledge transfers, rather than operating in a silo.
   
   
3. Offer competitive packages and flexibility:
   In-demand QA/RA professionals often juggle multiple offers. Benchmark salaries and be ready to meet the market (for reference, a QA/RA Manager in Europe might command €75k - €110k+ depending on experience). Beyond salary, emphasise work-life balance, remote work options, and a sense of purpose in the role. Top candidates care about the company’s commitment to innovation and patient safety as much as the paycheck. If you’re a smaller diagnostics firm, you can compete by highlighting opportunities to make a real impact (versus being a cog in a big company). And once you’ve hired great people, invest in their growth to retain them. Losing a QA/RA lead mid-project can set back your IVDR timeline significantly.
   
   
4. Build a pipeline:
   Don’t wait until you desperately need a regulatory hire. Keep in touch with promising candidates and build an employer brand that QA/RA professionals recognise. Whether through content (e.g. publishing insights on IVDR compliance) or engaging in industry forums, make your organisation visible to the talent you’ll eventually need. Remember, recruitment in this space is a year-round strategic activity, not just a backfill task.

Internally, also promote cross-functional exposure, let your R&D, manufacturing, or quality engineers shadow RA processes. This breaks silos and creates backup knowledge within the company. The goal is a team that is agile, well-rounded, and resilient. If one person leaves, others can step up. Under IVDR, that continuity is critical.

Technology and culture are two often-overlooked elements of building your IVDR team’s success:

Integrate Modern QMS Tools

Equip your team with the right tools. Spreadsheets and paper-based systems won’t cut it when you’re managing thousands of pages of technical documentation, multiple SOP versions, and audit trails. Modern eQMS software and document management systems can automate reminders (for CAPAs, PMS reports, training due dates), control versions, and streamline audits. According to a 2023 RA report, 88% of medtech companies have adopted digital tools for regulatory processes, and those who invest in Regulatory Information Management (RIM) and eQMS see higher productivity gains. Freeing your QA/RA staff from manual grunt work lets them focus on strategic tasks like risk assessment and gap analysis.

Additionally, consider tools for regulatory intelligence (to track IVDR guidance updates or Notified Body opinions) and learning management to keep staff training records up-to-date. Having a digitally savvy QA/RA team not only improves efficiency, it also appeals to talent: the best QA/RA professionals want to work with companies that prioritise smart processes, not ones stuck in outdated ways.

Finally, build a culture of compliance across your organisation. Your QA/RA team will be most effective when the entire company, from R&D scientists to sales reps, understands that quality and regulatory compliance are everyone’s job. Encourage cross-training sessions where QA/RA educate other departments on IVDR impacts. Celebrate compliance milestones (like completing a successful audit or submitting a technical file) to reinforce their importance.

Make it safe for team members to flag issues early. An open culture where, say, an engineer can approach QA about a testing deviation without fear will help your QA/RA team catch and resolve problems before they escalate. This proactive attitude can prevent major non-compliance incidents. (Notably, 61% of medtech firms reported a serious compliance issue in the past two years, often due to internal oversight lapses. The lesson: vigilance at all levels is key.)

And keep learning: regulations evolve, and so should your team’s knowledge. Budget for your QA/RA staff to attend trainings, conferences (like RAPS Euro Convergence or MedTech Europe workshops), and obtain relevant certifications. This not only improves your compliance readiness but also signals to employees that you invest in their growth, a big factor in retention.

Direct, consultative leadership is crucial in QA/RA. Lead by example: if you’re heading QA/RA, show that you’re hands-on and approachable. Encourage your team to find solutions, not just point out problems. As one QA/RA specialist advises, focus on the critical 20% of activities that drive 80% of compliance impact. By prioritising effectively and empowering your team, you’ll maintain control even when resources are tight.

The IVDR transition is challenging European diagnostics companies to raise their game. A compliance-ready QA/RA team is your best defence against the regulation’s complexity, and your best offence for gaining a competitive advantage. With the right mix of skilled people, smart hiring and training strategies, and a culture that values quality, you can navigate IVDR without derailing your innovation.

QA/RA and HR leaders in IVD firms should start building their teams now, if they haven’t already. Every day counts when May 2025 is around the corner for QMS compliance, and Notified Bodies’ calendars are filling up for conformity assessments. The good news? Those who invest in strong QA/RA teams will not only meet IVDR requirements but also drive better overall performance. Compliance done right can streamline operations, speed up product launches, and ultimately protect patients, and that is a win for everyone.

Remember, you don’t have to do it alone. Lean on internal talent, external recruiters, and industry experts to fill the gaps. Stay informed through authoritative sources like MedTech Europe and regulatory consultants for the latest updates. In this high-stakes transition, talent is your differentiator. Build your IVDR-ready team, and you build the foundation for sustainable success in the EU diagnostics market.

Looking for support in hiring IVDR compliance talent or need guidance on structuring your QA/RA team?

Our team at Panda specialises in connecting diagnostics and MedTech companies with top QA/RA professionals who can navigate IVDR compliance from day one. Reach out to Cristina below to learn more about how we can help your organisation grow.

Email: c.ruiz@panda-int.com
Phone: +31 (0)20 2044 502