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  • 1.  Salary Range for IVD Regulatory Affairs?

    Posted 23-Jul-2021 13:39

    Hello.  For the RA community I am trying to gauge an approximate salary range for a regulatory professional who can start at a company and on their own assemble an EU Technical File as well as a 510(k).  This assumes a college degree.  The location is in San Diego and it is for an IVD product.  Thanks for your comments.



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    Frank Pokrop, RAC
    Sr. Director, Regulatory Affairs
    Carlsbad CA
    United States
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  • 2.  RE: Salary Range for IVD Regulatory Affairs?

    Posted 24-Jul-2021 11:53
    Frank,

    Did you review the RAPS Scope of Practice and Compensation Review?

    Its available here: Scope of Practice Survey | RAPS
    Raps remove preview
    Scope of Practice Survey | RAPS
    View this on Raps >

    Paul

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    Paul Brooks
    Salt Lake City UT
    United States
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    Original Message


  • 3.  RE: Salary Range for IVD Regulatory Affairs?

    Posted 27-Jul-2021 14:01
    IMHO,

    A range in USD$ for a self-starting experienced IVD consultant to prepare Tech Files and a CE & 510(k) submission would be somewhere in the $200-$350 /hr range. (DOE)

    Hiring a similar SME FTE in SoCal would be in the $175-$250K /yr range. (DOE)

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    Michael Chellson
    MSc, RAC
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    Original Message


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