It’s important to recognise that unfilled QA/RA positions don’t just inconvenience the regulatory department – they pose a strategic risk to the entire business. Quality and regulatory professionals are the linchpin holding your compliance status (and thus your market access) intact under IVDR’s heightened oversight. Leaving these roles unfilled or under-resourced can lead to significant consequences:
Delayed Certifications and Market Launches:
Regulatory Affairs is no longer a back-office function; it directly determines market access and revenue timing. Without sufficient RA staff, critical tasks like compiling IVDR-compliant technical files, answering Notified Body questions, and managing new clinical evidence requirements inevitably slow down. Many companies are already experiencing this – projects ready for launch get stuck in regulatory bottlenecks. The difference between progress and delay often comes down to securing the right regulatory leadership at the right moment. If you can’t execute submissions on time due to an RA vacancy, competitors with the right talent in place will beat you to market.
Audit Findings and Compliance Failures:
On the quality side, the IVDR imposes annual Notified Body audits and rigorous post-market surveillance duties. Without strong quality leadership, organisations face audit findings, delayed approvals, and operational risk. Many EU diagnostics manufacturers report that quality resource constraints at the management level leave them vulnerable. In fact, weak quality leadership is a recurring factor in failed audits and prolonged remediation programs.
Increased Operational Strain:
Every QA/RA vacancy means existing staff must juggle extra responsibilities. This can lead to burnout and mistakes, creating a vicious cycle. For example, if your sole RA manager is trying to oversee five IVDR submissions at once due to an unfilled RA specialist role, something will eventually give – perhaps a missed regulatory update or a documentation error that triggers an audit finding. Likewise, in manufacturing, lacking a dedicated quality systems manager means production changes or supplier issues might not get proper regulatory assessment, increasing the risk of non-compliance. These gaps are not theoretical: industry analyses have linked understaffed QA/RA teams to issues like documentation backlogs, slower nonconformance resolution, and higher complaint rates. And since IVDR requires a designated PRRC (with 4+ years of RA/QA experience in IVDs) accountable for compliance, not having a qualified person in that seat isn’t just risky – it’s illegal.
Missed Opportunities and Lost Revenue:
Beyond avoiding negatives, filling QA/RA roles is about enabling positives. A strong RA leader can find creative regulatory pathways to expand your product into new markets or indications faster. A savvy QA manager can streamline your quality system, enabling smoother scale-up and perhaps even reducing cost-of-poor-quality. Conversely, leaving these roles vacant means missed opportunities – e.g. delaying a new assay launch by six months could mean millions in lost revenue and a weaker market position. As one example, an EU diagnostics scale-up recognised their clinical evidence generation was lagging; they hired a Clinical Studies Project Manager with IVD experience to accelerate their performance studies and keep submissions on track. Companies that invest in the right talent at the right time are positioning themselves to leap ahead, while those that hesitate see plans stall.
