Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, I have extensive senior management Regulatory experience in med device. But I am interested into moving over to the drug/bio side of the industry. I am wondering if anyone has experience making this transition and what you would recommend for steps to do so. The RAC is on my list to do. I would prefer to not start completely all over as I can not financially afford that. And my current company does not have a drug/bio side that I can work with to gain experience. Unfortunately, my full network is very med device heavy. Any thoughts are appreciated.

Hello,
This is definitely an interesting transition with a lot of new experiences to gain. If I were to do it myself I would look for a position that allowed me to gain new drug specific knowledge while profiting best from my MD past. I would be looking for a position in the field of Drug-Device combination products with the following consecutive step plan:
1) Being responsible for the MD device part of combination products while entering/learning about the drug regulation part
2) Being responsible for combination products for MD and drug part
3) Work on other drug only products

I believe that there are enough opportunities in the business to follow such a plan. To gain already some drug regulation knowledge before starting that path might be useful. This would also help to better understand what you will be working on in the future and to see if it really suits you.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Epalinges
Switzerland
------------------------------

Original Message:
Sent: 07-Mar-2022 09:46
From: Anonymous Member
Subject: Senior RA med device experience but want to move into drug side

This message was posted by a user wishing to remain anonymous

Hello, I have extensive senior management Regulatory experience in med device. But I am interested into moving over to the drug/bio side of the industry. I am wondering if anyone has experience making this transition and what you would recommend for steps to do so. The RAC is on my list to do. I would prefer to not start completely all over as I can not financially afford that. And my current company does not have a drug/bio side that I can work with to gain experience. Unfortunately, my full network is very med device heavy. Any thoughts are appreciated.

This message was posted by a user wishing to remain anonymous

I would echo trying to get into combination products (the area I work in), but with a pharma company. Most of the regulatory people we hire in that area are former device regulatory people, because the understand the different requirements (e.g. design controls) that the pharma regulatory people don't understand.
Original Message:
Sent: 08-Mar-2022 02:13
From: Enrico Schurig
Subject: Senior RA med device experience but want to move into drug side

Hello,
This is definitely an interesting transition with a lot of new experiences to gain. If I were to do it myself I would look for a position that allowed me to gain new drug specific knowledge while profiting best from my MD past. I would be looking for a position in the field of Drug-Device combination products with the following consecutive step plan:
1) Being responsible for the MD device part of combination products while entering/learning about the drug regulation part
2) Being responsible for combination products for MD and drug part
3) Work on other drug only products

I believe that there are enough opportunities in the business to follow such a plan. To gain already some drug regulation knowledge before starting that path might be useful. This would also help to better understand what you will be working on in the future and to see if it really suits you.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Epalinges
Switzerland

Original Message:
Sent: 07-Mar-2022 09:46
From: Anonymous Member
Subject: Senior RA med device experience but want to move into drug side

This message was posted by a user wishing to remain anonymous

Hello, I have extensive senior management Regulatory experience in med device. But I am interested into moving over to the drug/bio side of the industry. I am wondering if anyone has experience making this transition and what you would recommend for steps to do so. The RAC is on my list to do. I would prefer to not start completely all over as I can not financially afford that. And my current company does not have a drug/bio side that I can work with to gain experience. Unfortunately, my full network is very med device heavy. Any thoughts are appreciated.

This message was posted by a user wishing to remain anonymous

I, a medical device RA professional who is looking for a new job, had recently come across with an orphan drug company which has a very small medical device division. 
They are recruiting medical device RA stuff, however, as their medical device division is very small, they told that the newly employed staff might be asked to work on drugs. 

I just want to mention that there is this kind of opportunity, thought it should be rather rare case.
Original Message:
Sent: 08-Mar-2022 08:59
From: Anonymous Member
Subject: Senior RA med device experience but want to move into drug side

This message was posted by a user wishing to remain anonymous

I would echo trying to get into combination products (the area I work in), but with a pharma company. Most of the regulatory people we hire in that area are former device regulatory people, because the understand the different requirements (e.g. design controls) that the pharma regulatory people don't understand.
Original Message:
Sent: 08-Mar-2022 02:13
From: Enrico Schurig
Subject: Senior RA med device experience but want to move into drug side

Hello,
This is definitely an interesting transition with a lot of new experiences to gain. If I were to do it myself I would look for a position that allowed me to gain new drug specific knowledge while profiting best from my MD past. I would be looking for a position in the field of Drug-Device combination products with the following consecutive step plan:
1) Being responsible for the MD device part of combination products while entering/learning about the drug regulation part
2) Being responsible for combination products for MD and drug part
3) Work on other drug only products

I believe that there are enough opportunities in the business to follow such a plan. To gain already some drug regulation knowledge before starting that path might be useful. This would also help to better understand what you will be working on in the future and to see if it really suits you.

Kind regards,
Enrico

------------------------------
Enrico Schurig
Epalinges
Switzerland

Original Message:
Sent: 07-Mar-2022 09:46
From: Anonymous Member
Subject: Senior RA med device experience but want to move into drug side

This message was posted by a user wishing to remain anonymous

Hello, I have extensive senior management Regulatory experience in med device. But I am interested into moving over to the drug/bio side of the industry. I am wondering if anyone has experience making this transition and what you would recommend for steps to do so. The RAC is on my list to do. I would prefer to not start completely all over as I can not financially afford that. And my current company does not have a drug/bio side that I can work with to gain experience. Unfortunately, my full network is very med device heavy. Any thoughts are appreciated.