Aligning Education with Career Goals in Regulatory

[Aspiring_Regulatory]

Hi all

I’m writing to seek career and educational guidance.

I have a Bachelor’s Biomedical Engineering degree and work experience as clinical engineer (2y), regulatory engineer (2y) and R&D engineer (1y) in a class 3 medical device company.

My aim is to be become a Lead External auditor for a notifying body and then grow in hierarchy.

I am looking to do my Master’s degree preferably in Europe.

1. Which courses can lead me towards my goals?
2. Is it worth it to become an external auditor or are there other opportunities in the regulatory field.
3. What salaries can I expect if I work in this field in the UK and Europe ?

PS: I want to have a high salary within next 5 years.

 

[MrTetris]

Hi Aspiring, basically any master course in biomedical engineering in any public university in Europe will help you pursuing your objective. You already have the necessary esperience to start a regulatory career in a private medical company, and then move to a notified body at the first occasion.

 

[MrTetris]

Salaries might differ significantly from a Country to another. You have around 5 years of experience, but not as an auditor, so you can expect something in the middle range, from 2000 euro/month net in Italy or Spain to something probsbly close to 3000 euro/month in Germany or the Netherlans (rough estimate). A nice salary for an employee, but do not expect to become rich in the short term

 

[Jean_B]

Hi all

I’m writing to seek career and educational guidance.

I have a Bachelor’s Biomedical Engineering degree and work experience as clinical engineer (2y), regulatory engineer (2y) and R&D engineer (1y) in a class 3 medical device company.

My aim is to be become a Lead External auditor for a notifying body and then grow in hierarchy.

I am looking to do my Master’s degree preferably in Europe.

1. Which courses can lead me towards my goals?
2. Is it worth it to become an external auditor or are there other opportunities in the regulatory field.
3. What salaries can I expect if I work in this field in the UK and Europe ?

PS: I want to have a high salary within next 5 years.

Besides the generic requirements directly derived from the EU MDR, there's also the typical practices.

Core in these that I often have to check for substantiating competence is a filled in NBOG F 2014-2. The auditor usually fills these in/provides the substantiation. The notified body then has to evaluate whether it is sufficient.

At the moment an empty NBOG F 2014-2 is available at https://view.officeapps.live.com/op...eu/Doks/NBOG_F_2014_2.doc&wdOrigin=BROWSELINK
It also refers to a guide: https://www.doks.nbog.eu/Doks/NBOG_BPG_2014_2.pdf
Both sourced from NBOG Documents
These will give you more detail for your possible paths.

Note that in essence you get "flavours" of auditors regarding products and competences, that can only fit with certain notified bodies. Check the Nando database at EUROPA – European Commission – Growth – Regulatory policy - SMCS to see which codes fit the flavour you are going for.
The codes are explained in MDCG 2019-14. Notified bodies must also substantiate competence for such specific codes on a per auditor level.

 

[Aspiring_Regulatory]

Salaries might differ significantly from a Country to another. You have around 5 years of experience, but not as an auditor, so you can expect something in the middle range, from 2000 euro/month net in Italy or Spain to something probsbly close to 3000 euro/month in Germany or the Netherlans (rough estimate). A nice salary for an employee, but do not expect to become rich in the short term

Thank you! I also want to keep few other options open. I want to gain knowledge and exposure for patent engineering. Would this still be the correct Master’s and career pathway?

 

[MrTetris]

Thank you! I also want to keep few other options open. I want to gain knowledge and exposure for patent engineering. Would this still be the correct Master’s and career pathway?

More or less... according to my experience, many companies keep patent management and regulatory affairs separate. Patent is more for legal+development engineers, while regulatory people are specialized in Medical Device Regulation or FDA regulation, which do not really govern patent, but product development, production and distribution. However, I cannot exclude that in some companies these functions might overlap.