Hallo Monir, it is really amazing how you are creating such a variety of videos to give us insights on IVDR and MDR. Here regarding the hiring process, I would like to ask a question for the position regulatory affairs manager. After the first interview and when people get into the second interview, e. g. meet the team and trying out some tasks. What do you think could be the potential tasks for the candidates?
Hi Yun. Thanks for your message. Regarding your question, I must say that it depends on the type of tasks that rhe manager has to do. But usually, I create a small exercise like « here is a label, can you spot a mistake » or I build a case for a product and I ask to identify the class of it and define a strategy for submission. Even if he make a mistake, the objective will be to understand what is the way he will go for the challenge and see if he is conpletely stuck or if he tries to find some way. Once I gave a candidate an impossible challenge and wanted to see how he would act under pressure. Remember the objective is not a good answer but the behavior of the candidate.
I am a Regulatory Affairs Consultant and have been asked to complete a long skills test or exam for some clients. One hiring manager requested it after a lengthy interview. It was not one question, it was similar to exams that I have taken in Grad school. I did not have the bandwidth nor time to complete it. The 2nd client requested from the agency for potential candidates to complete a skills exam before allowing the agency to submit resumes for the position for an interview. Finally, the client would not disclose their name. I initially stated ok but thought about it and declined. My competency could be assessed during the interview if the client knows how to interview. I am at the disadvantage as what if I take this test and don't get an interview, have no idea who client is (can't research the company or may be a company I am not interested in working with), etc. You are correct, these assessments remind me of SAT test I took pre-college, which I scored poorly but I graduated with a 3.8 GPA. Give me an interview, ask the questions during interview.
@@breeanders15 agree Bree. But some of those tests are not to be completed. Sometime they just want to see how you behave when doing them. They see if you are orgnaized or stressed or if you are doing well. But you should really act real and not fake. If they need someone organized and you are not then they will discover that anyway later so no need to lose time now.
Thank you for all your valuable content, Monir. Have you by any chance received an updates regarding the expiration dates for Free Sale Certificates being extended? I believe most FSC expire on 5/25/22 because that's when IVDR was supposed to go into full effect. Since IVDR has been postponed (ours are class C IVDs), I'm trying to figure out if our FSC can be extended. Our Authorized Rep in Greece hasn't been able to get an answer yet. I'm just curious if you have heard anything about this.
The FSC has no expiration date, but the country where you will sell your product can ask you a new one because of the change of regulation. So this is not really a question of extension but of proof that you are still complying to the current law. So your FSC will still continue to work until a foreign country is asking you for a renewal
You are spot on with landing the candidate. Most companies only care about their needs, not the candidates.
Hallo Monir, it is really amazing how you are creating such a variety of videos to give us insights on IVDR and MDR.
Here regarding the hiring process, I would like to ask a question for the position regulatory affairs manager. After the first interview and when people get into the second interview, e. g. meet the team and trying out some tasks. What do you think could be the potential tasks for the candidates?
Hi Yun. Thanks for your message. Regarding your question, I must say that it depends on the type of tasks that rhe manager has to do. But usually, I create a small exercise like « here is a label, can you spot a mistake » or I build a case for a product and I ask to identify the class of it and define a strategy for submission. Even if he make a mistake, the objective will be to understand what is the way he will go for the challenge and see if he is conpletely stuck or if he tries to find some way. Once I gave a candidate an impossible challenge and wanted to see how he would act under pressure. Remember the objective is not a good answer but the behavior of the candidate.
I am a Regulatory Affairs Consultant and have been asked to complete a long skills test or exam for some clients. One hiring manager requested it after a lengthy interview. It was not one question, it was similar to exams that I have taken in Grad school. I did not have the bandwidth nor time to complete it. The 2nd client requested from the agency for potential candidates to complete a skills exam before allowing the agency to submit resumes for the position for an interview. Finally, the client would not disclose their name. I initially stated ok but thought about it and declined. My competency could be assessed during the interview if the client knows how to interview. I am at the disadvantage as what if I take this test and don't get an interview, have no idea who client is (can't research the company or may be a company I am not interested in working with), etc. You are correct, these assessments remind me of SAT test I took pre-college, which I scored poorly but I graduated with a 3.8 GPA. Give me an interview, ask the questions during interview.
@@breeanders15 agree Bree. But some of those tests are not to be completed. Sometime they just want to see how you behave when doing them. They see if you are orgnaized or stressed or if you are doing well. But you should really act real and not fake. If they need someone organized and you are not then they will discover that anyway later so no need to lose time now.
Thank you for all your valuable content, Monir. Have you by any chance received an updates regarding the expiration dates for Free Sale Certificates being extended? I believe most FSC expire on 5/25/22 because that's when IVDR was supposed to go into full effect. Since IVDR has been postponed (ours are class C IVDs), I'm trying to figure out if our FSC can be extended. Our Authorized Rep in Greece hasn't been able to get an answer yet. I'm just curious if you have heard anything about this.
The FSC has no expiration date, but the country where you will sell your product can ask you a new one because of the change of regulation. So this is not really a question of extension but of proof that you are still complying to the current law. So your FSC will still continue to work until a foreign country is asking you for a renewal
Amazing! Thank you,
The ghosting is a pet peeve for me. If I am asked about an agency or client that does this, I don't recommend nor will ever do business with again.
This happens but we never know the reason. Always a mystery for me
Great content 👍 ThX