Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear all,


I am working in the regulatory affairs field for the past 4 years in a different country than my place of birth. From regulatory perspective I have sufficient exposure as I have already made couple of submissions to the FDA as well as working on regulatory submissions for other areas such as EU (for MDR). But, I don't want to keep limiting myself only into the Regulatory field. I also want to go deeper into the 'Quality' field. However, due to language barrier I am never assigned with broader task in quality although I have shown repeated interests as well as capability by assisting the quality team multiple times. This is because most of the quality things are written in a language which I cannot read/write/speak, so obviously my employer is reluctant enough to assign any independent quality related job. Obviously I could change my job to another company, but the situation is more or less same in other companies as people here are not comfortable with English as a language. So, that option is also not futile to me. 

So I would like to know, how I can learn all the 'Quality Aspects' of a medical device on my own and over the time I could feel more comfortable/experienced with it. First of all, I am planning to take an 'Internal Auditor' course/certificate on my own. Is there any other way to gain more knowledge/experience!

Dear Anonymous,

I think by taking an Internal Auditor course you are taking a step in the right direction, it will allow you to understand the requirements from a Quality perspective. I would also say to utilize as many free resources as you can.  There are many free ebooks and webinars out there that you can look at to gain knowledge and understanding. Sign up for as many of them as you can.

for example - BSI, Greenlight Guru, Quality Digest, Reed Tech, CDRH Learn to name a few resources.

------------------------------
Keri Froese RAC
Manager Compliance & Regulatory Affairs
Healthsign
Ottawa
Canada
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Original Message:
Sent: 28-Mar-2021 04:44
From: Anonymous Member
Subject: How to learn 'Quality'

This message was posted by a user wishing to remain anonymous

Dear all,


I am working in the regulatory affairs field for the past 4 years in a different country than my place of birth. From regulatory perspective I have sufficient exposure as I have already made couple of submissions to the FDA as well as working on regulatory submissions for other areas such as EU (for MDR). But, I don't want to keep limiting myself only into the Regulatory field. I also want to go deeper into the 'Quality' field. However, due to language barrier I am never assigned with broader task in quality although I have shown repeated interests as well as capability by assisting the quality team multiple times. This is because most of the quality things are written in a language which I cannot read/write/speak, so obviously my employer is reluctant enough to assign any independent quality related job. Obviously I could change my job to another company, but the situation is more or less same in other companies as people here are not comfortable with English as a language. So, that option is also not futile to me.

So I would like to know, how I can learn all the 'Quality Aspects' of a medical device on my own and over the time I could feel more comfortable/experienced with it. First of all, I am planning to take an 'Internal Auditor' course/certificate on my own. Is there any other way to gain more knowledge/experience!