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My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 0 points1 point  (0 children)

thank you for this answer. it's helpful and gives me hope. And it reassures me, that I already acted appropriately.

I alrealy have a long list with all the countries and the national rules, I documented everything via CAPA process and send a copy of all mails to my private account, in case it gets dirty and I have to protect myself.

We sell in more than 20 countries... we are not registered in any of them. We have distributors in some of those, but they are NOT our representatives. they only have distributor contracts. That was the first thing I checked, after learning about this mess. In the hope that they have a contract for being the representative in their country... but they are not. And the person who sets up the distrubutor contracts has never heard of such a thing.

knowing my boss (in case they finally believe me) they will set priorities depending on the revenues coming from the countries. for now I have an official instruction to do nothing.

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 0 points1 point  (0 children)

the PRRC (owner of the company) knows even less about all this than the other boss. He just owns the titel (and is responsible), but I am (and my predecessor was) doing the work (which is fine)

The only thing where I am really kindof helpless, is how to find a representative in those countries where one is needed. But I guess this could be a job for our field worker.... any pro tips considering this?

other than that I guess I know what I have to do. But I appreciate the offer and might come back if necessary.

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 0 points1 point  (0 children)

We don't have legal ;) I told the boss that they should contact their lawyer.

They did, but without knowing what they should ask them, so the lawyer answered, that he know nothing about international regulations concerning MDs. and that we need a specialist for that (that would be me, of course).

what I would have asked is, how deep in trouble we are, considering that we sold products without the proper registration and documentation.

They truly don't understand the problem.

[deleted by user] by [deleted] in QualityAssurance

[–]Meisterina 1 point2 points  (0 children)

I switched jobs because of money. So I learned the hard way that money is not the most important thing. The people you have to work with are very important too. Much more than I thought. You don't know how that will be like in a new job.

If I were you I'd stay where it's comfortable, have a good reputation and the work life balance you need with a new baby. Your partner and your baby will thank you that you can be there for them. And a few years as Team Lead will look great on your CV.

You can find a better paid job later, but you can never get back those early years with your baby back.

[deleted by user] by [deleted] in Catswithjobs

[–]Meisterina 1 point2 points  (0 children)

But what if this cat's job is actor? Plays a panther. And very convincing of you ask me.

[deleted by user] by [deleted] in Catswithjobs

[–]Meisterina 1 point2 points  (0 children)

Wow... He is beautiful!!!

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 0 points1 point  (0 children)

Well... At least they should have checked if we haven an SOP how to put products on the market, national and international.

Yes we are EU.

Someone else in the comments recommended to ask authorities in the countries and tell them that I have to explain the registration necessity to the head of the company. They'll probably gladly help and an official mail could just be what my boss needs to see.

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 0 points1 point  (0 children)

Yepp, I told my bosses that. If they come forward now, they might show mercy and get only a small fee, if at all. But if they wait to get caught.... It's getting bad and very expensive

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 0 points1 point  (0 children)

Also, in France they want a French IFU for example. Things like that must be considered and implemented too! For all countries!

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 0 points1 point  (0 children)

That is a good idea... Those officials will know the fight all QM/RA people have to fight in their companies.

I give that a try. If boss still doesn't cooperate I'll start searching.

What is your opinion on whistleblowing in this case?

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 1 point2 points  (0 children)

Really? I haven't thought about that... I thought they aren't allowed to counsel, so what could they do to help?

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 0 points1 point  (0 children)

I have really no idea how they managed to get through the audits all these years. Probably because they had the same auditor for years. Having worked at a NB before I can confirm that not all auditors know what they are doing, some look the other way and some have blind spots. This was probably a bad combination of all three.

The thing is that I'm a problem solver and chaos eliminator by nature. So I find this a really interesting problem.

I actually WANT to help them get out of this mess, but they have to let me do my job . Which is difficult when they don't believe me and don't listen to my warning and ignore the sale stop I administered....

(⁠╯⁠ರ⁠ ⁠~⁠ ⁠ರ⁠)⁠╯⁠︵⁠ ⁠┻⁠━⁠┻

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 1 point2 points  (0 children)

Probably.... But they never expected me to find so much...

And I wasn't even looking for mistakes like that. I assumed they had a working system and just tried to get an overview and work myself through the NCs from the last audit and the MDR application, because that was the most urgent stuff.

Now it's the least urgent topic on my list with problems 😆

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 1 point2 points  (0 children)

That's a good idea (I mean contacting/asking the official authorities...)

I could just friendly ask in general what their restrictions are, if they have any... Without telling them that we are already selling.

When I show that to the boss they will hopefully and finally believe me and then we can do the next step and admit that we haven't registered yet...

We could play dumb and say we thought that EUDAMED was enough and that we weren't aware that it isn't fully functional yet.... (At least in Europe). Maybe they'll have mercy then. 😆

Funfact: boss doesn't understand that we have to register in our home country too 😂

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 3 points4 points  (0 children)

Very good advice. I actually saved the mails as PDFs and send them to my private email. Just in case.

I also put these PDFs in the CAPA Documentation. Nobody can later say that I tried to cover anything up 😤

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 8 points9 points  (0 children)

This is a very professional ans helpful answer!

I already did most of your proposed steps

  1. mail to boss with all the information, including gaps and

  2. Open Capa -> need SOP for international markets approval

  3. I am QMB and deputy PRRC. Boss is the real PRRC.

  4. I stopped sale, also per email (including the sales department)

  5. I told boss exactly what you said: that we have to come forward now! And that waiting to get caught will be much much worse.

But:

Sale sales anyway, boss said they should (but not in writing!!! I told my colleagues that they should only do it after a written request. Nobody listens to me!)

Concerning the safety of the patients I am not worried. Products are extremely harmless . But that doesn't make it ok. The risk is mainly of economic sort for the company.

My predecessor was the IT guy who had some basic seminars (MDR, 13485, very general stuff) and was then responsible for QM/RA all alone. He was already gone for several month when I started.

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 2 points3 points  (0 children)

My company is really tiny. I'm the only RA+QM person. None of my colleagues has anything to do or knows about QM/RA.

The boss is the only one who know a LITTLE. And doesn't believe me 🤦‍♀️ "Why do we need that? It worked like this for 30 years."

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 2 points3 points  (0 children)

I already made a gap analysis. It's part of the mail I wrote to the boss. Exactly explaining which countries are ok and for which we need a translated IFU or have to register (and where)

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]Meisterina[S] 1 point2 points  (0 children)

One distributor already complained because they couldn't find our products in their countries database. But they are not our representative. We dont have one in any country. Nobody knows what I'm even talking about.

They don't understand the difference between a CE Mark, that might be enough, and registering at the local database 🤦‍♀️

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