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  • 1.  Transition to Regulatory Affairs

    Posted 09-May-2021 19:29
    I am seeking to transition my career to Regulatory Affairs and would like a little advice. I currently am a Quality Assurance Manager at a food company with a RAPS Certification in Medical Devices and Pharmaceuticals. I have experience in R&D, microbiology, and quality assurance in the food industry but would like to transition to either the medical devices or pharmaceutical industry. Does anyone have some advice on how to use my extensive experience in a regulated industry to my advantage while seeking new employment in a different industry? Thanks!

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    Amy Miller
    QA Manager
    Vernon Center MN
    United States
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  • 2.  RE: Transition to Regulatory Affairs

    Posted 10-May-2021 10:42
    Amy, this can be a real challenge. That said, I would first start with mapping out your experience(s) to what you learned from your certificate and see where perhaps skills and requirements are similar. For instance, managing a QC lab may be similar, even if the exact tests are different. Writing test reports may be very similar, etc. Then try and find that first role in an area where the skills map closest. Having done this background work will really help your interviewing, as you will better be able to tell them "how you can help" in that particular role. Particularly, you might consider a med tech QA role at first, that can lead to an RA role later.

    Also, I'd tend to look for either smaller companies or small departments in bigger companies. There, the hiring managers tend to have a bit more flexibility to look at non-traditional candidates, unlike where HR controls all aspects.

    Another idea would be to find a company where they may make products in both types of categories, so you can leverage one skill while learning another.

    Most of all, be persistent. Switches like this take time, but eventually you can get to where you want to be.

    Ginger

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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  • 3.  RE: Transition to Regulatory Affairs

    Posted 11-May-2021 07:19
    Hi Amy 

    Ginger makes great points.  I would see your skills being very useful in company's QC role where the company has sterile devices because of need for talented people familiar with micro to assist in that interaction with sterilization and cleaning validations. I was lucky to find a small medical device company in 1996 to take a chance on me to be QC Manager based on my experience in QA And QC managers in small biopharmaceutical companies  here in the Twin Cities and testing companies in CA in the 80s.  But it was still a hard jump to switch industries to device and hard to work into regulatory from quality.  That seems easiest if you help with submission sections (author them) related to lab testing and just find an RA friend to allow you to do that.

    In development,  RA relies so heavily on QA/QC allies on the development team, that might be a way in when a job opening comes.

    Good luck!

    Other Ginger

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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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  • 4.  RE: Transition to Regulatory Affairs

    Posted 10-May-2021 12:52
    Hi Amy,

    Sounds like you have solid experience and the RAC is a big credential for you to move into the Medical Device industry.  While there are graduate programs at SCSU and St. Thomas focused on Regulatory Affairs in med devices that is a big commitment and expense.   

    I would recommend you view and train yourself on the many FDA video learning tools on the FDA website under CDRH Learn. Here is the link:

    https://www.fda.gov/training-and-continuing-education/cdrh-learn

    Explore the categories and drop downs and key in on the topics that will acquaint you with the end to end Total Product Life Cycle of the FDA regulatory process and requirements.  Translate that knowledge to the application and interview process and it will help.

    There are literally hundreds of open Regulatory Affairs positions in the medical device industry in the Twin Cities so you have a great opportunity ahead of you.

    I invite you to connect with me on Linkedin to discuss further. 


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    Mac McKeen, RAC, FRAPS, MBA
    Fellow, Regulatory Science
    Boston Scientific
    Maple Grove MN
    United States
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  • 5.  RE: Transition to Regulatory Affairs

    Posted 24-Mar-2023 10:17

    Hello Amy,

    I am not sure if you're still looking to break into RA, but if you are - please send me a message and we can talk.  I am hiring for a 1-year contract role for an RA associate. There is a possibility the contract could extend, or could convert to permanent - but several factors impact that.  Regardless of if my opportunity is a fit for you, I'd still be happy to connect and see if I can help you identify some other opportunities within the company I work in. 



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    Katherine Doll Kanne
    Principal Regulatory Affairs Specialist
    Saint Paul MN
    United States
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  • 6.  RE: Transition to Regulatory Affairs

    Posted 24-Mar-2023 10:41

    Good morning, I am back on the job market and would love to break into regulatory affairs.  Can you please reach out via email about this potential opportunity? My email is amylmiller@protonmail.com.



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    Amy Miller
    QA Manager
    Vernon Center MN
    United States
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