Regulatory Open Forum

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  • 1.  Working field

    This message was posted by a user wishing to remain anonymous
    Posted 10-Feb-2019 09:27
    This message was posted by a user wishing to remain anonymous

    Hi

    Recent RAPS compensation survey indicated the there are more professional in Medical device (41%), IVD (5.4) Prescription drugs 27%, 14% Biologics. Does it mean that there are more opportunities in the medical device segment? Or data is skewed. Please comment.

    Regards


  • 2.  RE: Working field

    Posted 11-Feb-2019 08:48
    Personally, I think it is a little of both.  For example, empirically, if you look at the vast majority of posts in any particular month, the fact is that there is a skewing towards the device side of the ledger.  That could mean that there are more opportunities in the device field (possible especially considering the number of different areas and specialties within the device world!) or it could mean that device folks are just more active in the organization (again, lots of people who truly specialize in devices are on these posts) or it could mean that the organization is simply skewed towards devices in its actual membership.

    I can relate something that happened a few years back when I took the RAC exam - in the 100 questions that session, I am almost certain that about 60 of them were some how related to devices.  To be honest, at the time I was not specifically working in the device world and truthfully had little specific experience in the area which I am sure contributed to my missing the required score for credentialing by something like 2 points.  Some other folks that I know who have since taken the exam informed me that it has been the same in other sessions as well which is one major reason I have never retaken the exam - if I don't have the right experience to pass the exam then there is no reason for me to believe that taking the exam "again" would result in any difference.  Again, this is not about the exam but simply to point to the fact that the organization itself may be skewing towards the device world rather than other areas of FDA regulations like cosmetics, OTC, and tobacco.​

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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  • 3.  RE: Working field

    Posted 11-Feb-2019 13:16
    My bet would be a little of both. I would not believe that 41% of the jobs are in devices, compared to RX drugs 27%- if only because RX drugs tend to come from big companies and big pharma often has very specialized RA roles. My suspicion is that this specialization might at times mean there are fewer of these folks in RAPS (or at least active on RAPS), perhaps because they get their information on their specialty elsewhere and there are few places to do so in devices. Add to this the fact that there are many small companies in the device world, and many more submissions and types of submissions due to the device lifecycle and there are probably a few more RA folks in devices as compared to the market size.

    I agree with Victor that we have not yet caught up to the newer regulated areas like tobacco and cosmetics though. Of course, years ago (1993) when I joined RAPS, our complaint was it was all pharma-centric and nothing for devices. That has changed dramatically (and may have partly been only because the leadership was largely from pharma) and I suspect it will for these other areas over time as well.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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