510K Submission Authoring - Primary Contact

B

Bruce Banner

#1
I've been working very diligently on a 510K submission and recently we've had a new manager come in. The submission is ready to go out the door and the new manager has instructed me to remove myself as the primary contact and put his name, telling me that I would still get credit for authoring the submission. I originally listed him as alternate contact, but he was not satisfied with that.
As far as I know, if I am not indicated as Primary contact, I just lost credit authoring the submission.(outside world industry,fda perspective)
I feel like I did all the work and somebody is swooping in at the end to take all the credit.
What should I do in a situation like this?
 
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Stijloor

Staff member
Super Moderator
#2
I've been working very diligently on a 510K submission and recently we've had a new manager come in. The submission is ready to go out the door and the new manager has instructed me to remove myself as the primary contact and put his name, telling me that I would still get credit for authoring the submission. I originally listed him as alternate contact, but he was not satisfied with that.
As far as I know, if I am not indicated as Primary contact, I just lost credit authoring the submission.(outside world industry, fda perspective)
I feel like I did all the work and somebody is swooping in at the end to take all the credit.
What should I do in a situation like this?
Suggestions anyone?

Thanks!!

Stijloor.
 

Ajit Basrur

Staff member
Admin
#3
I've been working very diligently on a 510K submission and recently we've had a new manager come in. The submission is ready to go out the door and the new manager has instructed me to remove myself as the primary contact and put his name, telling me that I would still get credit for authoring the submission. I originally listed him as alternate contact, but he was not satisfied with that.
As far as I know, if I am not indicated as Primary contact, I just lost credit authoring the submission.(outside world industry,fda perspective)
I feel like I did all the work and somebody is swooping in at the end to take all the credit.
What should I do in a situation like this?
Bruce,

I understand how you feel on your Manager taking your work but does it not happen else where as well ? This could be just one incident but as you start working with him, you will have more such instances.

Why would you not make your Manager successful ? His success would bring you more successes.

Btw, each Organization will have just one FDA Agent so there would be many people in the organization who would be working but only this guy would be communicating with FDA, isnt it :)
 
B

Bruce Banner

#4
The manager has already expressed his grand plan to me. Going forward until a undertermined time all submissions will be worked on by me or somebody else, but his name would be the contact going out with the submission. So already I will be taking a backseat.
Being the contact is helpful to my career isn't it?
 

Ajit Basrur

Staff member
Admin
#5
The manager has already expressed his grand plan to me. Going forward until a undertermined time all submissions will be worked on by me or somebody else, but his name would be the contact going out with the submission. So already I will be taking a backseat.
Being the contact is helpful to my career isn't it?
You are correct. But what have you decided ?
 
B

Bruce Banner

#6
Well looks like to me, if I want to keep my job I lose on this one.
Fight it and I lose still.
Seems like not much to be done.
 
#7
It sounds like standard management behaviour.

I guess that many companies do work like this - if you look at the 510(k) summaries for the biggest companies they tend to only have 'top' names, and these companies do dozens of 510(k)s a month.

I too am working on one and am planing to get my name on the summary.

How about putting the whole thing together with the original summary and then when it gets published and your manager notices say "oh I am sorry - there must have been some mistake - I told them to update that page - it must have slipped through".

Good luck!
 
B

Bruce Banner

#8
It sounds like standard management behaviour.

I guess that many companies do work like this - if you look at the 510(k) summaries for the biggest companies they tend to only have 'top' names, and these companies do dozens of 510(k)s a month.

I too am working on one and am planing to get my name on the summary.

How about putting the whole thing together with the original summary and then when it gets published and your manager notices say "oh I am sorry - there must have been some mistake - I told them to update that page - it must have slipped through".

Good luck!
Heh, I'm pretty sure my days will be numbered if I try such a tactic.
 
M

MIREGMGR

#9
Being the Contact on a 510(k) in a corporate environment is generally recognized as a matter of hierarchy rather than expertise or authorship, I think.

You'll have to hope that whoever cares about your # of 510(k)s authored, will accept your listing of 510(k)s that you say you actually prepared even though a manager was the official Contact.

In such a circumstance, a competent hirer would assure that the applicant is interviewed by someone who has the knowledge level to ask a few questions that reveal whether the applicant is expert regarding 510(k) preparation in general and knows that particular 510(k), or not.

If your new manager is trying to claim authorship-credit for his/her own resume, they'd stumble badly in a competent hiring process.
 
B

Bruce Banner

#10
Being the Contact on a 510(k) in a corporate environment is generally recognized as a matter of hierarchy rather than expertise or authorship, I think.

You'll have to hope that whoever cares about your # of 510(k)s authored, will accept your listing of 510(k)s that you say you actually prepared even though a manager was the official Contact.

In such a circumstance, a competent hirer would assure that the applicant is interviewed by someone who has the knowledge level to ask a few questions that reveal whether the applicant is expert regarding 510(k) preparation in general and knows that particular 510(k), or not.

If your new manager is trying to claim authorship-credit for his/her own resume, they'd stumble badly in a competent hiring process.
This manager has done 510k's before, but looking at his history, its been a while. So for various reasons I assume he wants his name on this one, internal and external motives.
The extra injury to insult is that even on the so called "authored" line he has put his name there too, as if I needed his help and to belittle my efforts further....
It just makes it that much more harder for me to convince any future employer. :(
 
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