If you work in MedTech, especially in a small or mid-sized company, you may have noticed something early on:
Regulatory Affairs and Quality Assurance are often not clearly separated.
You might be reviewing/writing sections of a technical documentation in the morning, supporting a deviation in the afternoon, and preparing for a notified body audit in between.
At some point, it becomes hard to say where RA ends and QA begins.
And in many SMEs, there is no clean boundary.
This is not a mistake in structure. It is a reflection of how MedTech products are built under EU MDR and IVDR. Compliance is not a final step. It is embedded in the product lifecycle from design to post-market surveillance.
Three main reasons why RAQA exists:
Resources are limited. People wear multiple hats, and compliance responsibilities are shared rather than strictly divided.
The regulatory framework itself connects the two functions. Technical documentation, risk management, design controls, PMS, and QMS requirements are deeply interdependent.
Many SMEs operate with a very product-focused mindset. When you are working on one or a few products, it is more efficient to think in terms of one compliance system rather than separate functions.
But this changes as companies grow. And more importantly, it changes how you experience your role and how you should talk about it in interviews.
As companies scale, this integrated model starts to shift.
The main driver is complexity.
More products, more markets, more audits, more parallel development activities. At some point, it becomes necessary to introduce clearer ownership structures.
Regulatory Affairs starts to focus more on strategy, submissions, and regulatory intelligence. Quality Assurance focuses more on QMS governance, audits, and system oversight.
This separation is also important from a control perspective. It ensures clearer accountability and strengthens the robustness of the quality system in the eyes of auditors and regulators.
What was once efficient integration becomes structured specialization.
In this week’s career section, I explored what RAQA integration actually means for your role from a Regulatory Affairs perspective.
Today you will read in this issue:
a recall worth learning from
career advice worth exploring
MedTech voice to follow
A recall worth learning from
This week I have in my radar: A peanut allergen reagent from BÜHLMANN Laboratories.
This FSN wasn’t a device malfunction. It was a manufacturing defect that could silently produce the wrong clinical answer.
A peanut allergen reagent from BÜHLMANN Laboratories was recalled after an internal investigation found that some vials from a specific lot may be empty.
Up to 12% of vials in the affected lot may have received no allergen solution during filling while looking identical to properly filled vials from the outside.
The downstream risk:
Basophil activation cannot occur without allergen
Flow CAST® and CAST® ELISA assays return a negative result
The patient appears non-allergic to peanut
And no one in the lab would know the test had failed.
That’s what makes false-negative risks so dangerous in IVD diagnostics. The assay runs. The equipment works. The result looks valid, but the clinical conclusion is wrong.
A patient gets inappropriate reassurance. Dietary recommendations are incorrect. Further investigation is delayed. In rare cases, medical intervention becomes necessary.
Reagent-based IVDs are only as reliable as what’s inside the vial. If fill-volume verification isn’t robust enough to catch every empty vial before release, the error doesn’t show up in the lab, unfortuantely it shows up in the patient’s result.
The corrective action here is replacement and retrospective review of negative results.
But the real lesson sits upstream:
Fill-volume verification needs to catch 100%, not catch most
In-process controls for reagent dispensing are a patient safety control, not just a quality metric
A defect affecting only 12% of a lot can still justify a full FSCA when the clinical stakes are high enough
Partial lot defects with invisible presentation are some of the hardest to manage because you can’t know which vials are affected without testing them individually.
That’s exactly when robust manufacturing controls need to do the work before the product ever leaves the facility.
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Career advice worth exploring
If you have worked in an SME where RA and QA are intertwined, you are in a very specific and valuable position. But it only becomes an advantage if you frame it correctly.
The key question is not “did you do RA or QA tasks?”
The key question is: “Do you understand the system behind both?”
In interviews, there are a few things worth highlighting.
First, show that you understand the full product lifecycle. Not just submissions or audits in isolation, but how design inputs, risk management, documentation, and post-market activities connect.
Second, emphasize systems thinking. Explain how regulatory requirements translate into quality processes and how quality systems generate regulatory evidence.
Third, highlight your ability to operate in ambiguity. In SMEs, processes are often evolving. Roles are less defined. You are often helping shape structure while executing within it.
Fourth, focus on interface work. Much of SME RA/QA work is translation between technical teams, management, and external auditors or notified bodies.
Finally, and this is an important reflection point, acknowledge the trade-off. Working in SMEs gives you breadth, ownership, and visibility across the entire compliance system. But it can also blur functional depth and structure.
So a useful question to ask yourself is:
Do I want to work in a space where RA and QA are still one system, or in a structure where they are clearly separated and specialized?
There is no right answer. But there is a difference in what each environment will teach you.
MedTech voice to follow
Meet, Georg Digel, aka the CAPA whisperer for medical device companies.
He helps quality leaders strengthen NonConformity and CAPA processes, improve investigations, and stay audit-ready, without adding complexity or hiring more people. On LinkedIn, he also shares practical insights, eye-catching infographics, and high-value content on quality management, CAPAs, audits, and compliance, making complex topics easy to understand and apply.
That is it for this week! :)
Have a great two weeks and see you in the next issue!
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