Issue 3: I moved from pharma RA to MedTech RA. Here’s what surprised me the most.

When I told my ex-boss in Pharma RA that I was moving into an IVD company, she said:

“Puhh… that is a lot of risk management.”

At the time, I did not fully understand what she meant.
Now, two years into MedTech, I do.

Risk is everywhere.

Every decision, label, claim, and even small changes need to be justified from a risk perspective. In pharma, risk is often implicit. In MedTech, it is explicit, documented, and constantly evaluated.

That is why knowing your product is essential.

You cannot assess risk if you do not understand how the product works, what it does, and what could go wrong. Product knowledge and risk thinking go hand in hand.

If you are moving into MedTech, start here.
Understand your product deeply and let that guide your decisions.

That is what makes you trusted and effective in Regulatory Affairs.

A quote worth reflecting on

“Understanding the ‘why’ is what makes you trusted.”

I see a pattern with people new to Regulatory Affairs. They focus on the what:

• What does the regulation say?

• What document is required?

• What is the correct format?

That is natural. When you enter a new field, you look for structure. You want something clear to follow.

I did the same.

At the beginning, I was trying to understand how to do things correctly. I was looking for clear answers and the right way to interpret requirements.

Over time, I realized this only takes you so far.

At some point, you face a situation where the guideline is not fully clear. Something is missing, or more than one interpretation seems possible.

That is where people get stuck.

I have been there too. Reading the same paragraph again and again, looking for an answer that is not there.

What helped me move forward was a shift in thinking.

Instead of asking “what does it say?”, I started asking:

• What is this trying to prevent?

• What risk is behind it?

• Who is it protecting?

This made it easier to navigate uncertainty.

If you only rely on the what, you hesitate.
If you understand the why, you can explain your reasoning.

And that is what builds trust.

I first learned this during my time in research. Following a protocol step by step was not enough. When something failed, the only way forward was to understand the reasoning behind each step.

If you understood the why, you could adapt. If not, you were stuck.

It is the same in Regulatory Affairs.

Following guidelines is necessary. Understanding them is what allows you to work with them.

So learn the structure and the requirements. That part is important.

Then go one step further and ask yourself:

• Why is this required?

• What would happen if it was missing?

That is when things start to click.

And that is when others begin to trust your judgment.

A recall worth learning from

Sometimes, the device is not the problem. The packaging is.

This week, I have in my focus the loss of sterility due to packaging defects.

In one case, contact lenses (by Coopervision Manufacturing Limited) were recalled because of leaking blister seals. In another, an antibacterial wound gel (by Derma Sciences Inc.) was withdrawn due to packaging integrity failures.

In both cases, the product itself was not defective.

The problem was the sterile barrier.

Without an intact seal:

• Microbial contamination becomes possible

• The product may look normal but is no longer safe

• The risk shifts from performance to infection

What makes this challenging is that these defects are often not visible to the user.

For regulatory and quality teams, this reinforces a few key points:

1. Packaging validation is as critical as product validation

2. Sterile barrier integrity must be continuously monitored post-market

3. Traceability and rapid communication are essential in field actions

Take away:

A sterile device doesn’t need to break to become unsafe.

It just needs to become non-sterile.

Career Advice worth exploring

Why do you like Regulatory Affairs?

It sounds simple, but it’s one of the most revealing questions in an interview.

Hiring managers aren’t just listening for your answer. They’re trying to understand how you see the role:

• What draws your attention

• What you find meaningful

• How you think about the bigger picture

Some people focus on structure and compliance. Others on strategy, decisions, or collaboration.

None of these are wrong, but each reflects a different mindset.

Your answer shows how you think, what you value, and where you fit.

So don’t just prepare an answer, prepare an honest one.

Because in the end, it reveals more than you think.

Before you go, tell me:

That is it for this week! :)

Have a great week and see you in the next issue!

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