A good Regulatory Affairs Manager

Auxilium

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#1
Dear community,
I have a rather general question to you.
What qualitities does a good Regulatory Affairs Manager have in your opinion?
I started my career recently in this field and focus on the MDR, so the European Market.
My job experience is less than a year, actually only a few months.
I wonder what the "typical pathway" as a Regulatory Affairs Manager, e.g. for SaMD looks like and how I can become better at my job.
I think the most important thing I realised so far is getting to know the standards, learn how to interpret them in a lean but sufficient way and getting an inside look into the processes of the organisation.
However, I sometimes lack the skills to actually participate in "interesting" discussions such as new strategies, new markets etc.
That is something I definitely suck at currently and wanted to have an opinion on how and when the appropriate time is to target stuff like that.
Maybe you can also provide some story of your own career and other helpful advise for me?
Thank you very much
 
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#2
I'm not affiliated with them, but RAPS is probably a good organization to join. They have a lot of resources and offer a lot of training.

Standards are one thing but you also need to be an expert in the regulations; e.g., the MDR for the EU.
 

Cybel

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#3
The greatest improvements in my job have followed the most critical third part audits (FDA and Korea mainly) - so remember to consider these as a great worth opportunity, rather than a threat or a problem.
For the rest, attending to training courses, listening to others' experience and daily reading this forum :) will help a lot!
 

Auxilium

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#6
The greatest improvements in my job have followed the most critical third part audits (FDA and Korea mainly) - so remember to consider these as a great worth opportunity, rather than a threat or a problem.
For the rest, attending to training courses, listening to others' experience and daily reading this forum :) will help a lot!
I am so thankful for that comment, you seem like an open person! When do you think should I do such a thing? How did you feel you're ready for such a thing?
The greatest improvements in my job have followed the most critical third part audits (FDA and Korea mainly) - so remember to consider these as a great worth opportunity, rather than a threat or a problem.
For the rest, attending to training courses, listening to others' experience and daily reading this forum :) will help a lot!
 

Auxilium

Involved In Discussions
#7
I'm not affiliated with them, but RAPS is probably a good organization to join. They have a lot of resources and offer a lot of training.

Standards are one thing but you also need to be an expert in the regulations; e.g., the MDR for the EU.
Yea hey, thx for the reply but sounds like I'm already a bit more advanced than that, I hope I am not feeling too confident in here but my gut feeling says I definitely have that stuff under control (the first market area)
 
#8
Why is that in your opinion? Can you explain a bit please? :)
Because Quality is like a subset of Regulatory. Regulatory people have to review all kinds of quality system documents and records to determine what is reportable to the regulatory authority. If they don't understand why those records exist, they can't do their job.
 

Auxilium

Involved In Discussions
#9
Because Quality is like a subset of Regulatory. Regulatory people have to review all kinds of quality system documents and records to determine what is reportable to the regulatory authority. If they don't understand why those records exist, they can't do their job.
Thank you very much for that answer! Makes total sense. Do you have another advise for getting better and how to accelerate in the job?
 
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