Regulatory Open Forum

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  • 1.  Is there any certification that can be advantageous for my career and positively impact my resume?

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jul-2023 09:05
    This message was posted by a user wishing to remain anonymous

    I am pursuing an MSc in Regulatory Affairs focusing on Medical Devices at a Canadian university. I am interested in enhancing my knowledge in the regulatory field. I would like to know if there are any certifications available that would be advantageous for my career and make a positive impact on my resume.

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  • 2.  RE: Is there any certification that can be advantageous for my career and positively impact my resume?

    Posted 31-Jul-2023 17:03

    Hi,

    You can explore RAPS RAC certification, attend webinars, workshops, connections etc. to enhance your regulatory knowledge.



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    Nag Goutham Channagiri
    Regulatory Affairs Specialist
    United States
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  • 3.  RE: Is there any certification that can be advantageous for my career and positively impact my resume?
    Best Answer

    Posted 31-Jul-2023 17:34

    The first question is to define the scope of Regulatory Affairs. In particular, because of my background, I have a hard time distinguishing between Quality and Regulatory. Some companies combine them in the organizational structure and others keep them separate.

    Think of the practical applications. In a company that markets products in the US, Canada, and the EU there are two areas of practice. One is making the submissions to the regulators. The other is hosting audits and inspections. In both cases, there is a strong overlap between quality and regulatory.

    A suggestion on the regulatory side is a RAPS certification.

    A suggestion on the quality side is a Certified Biomedical Auditor from the American Society for Quality, ASQ. (They recently changed the name to better reflect the device aspect.)

    A suggestion for the EU-MDR is to attend a course and receive a certificate as a QPRC.

    Consider courses in auditing to specific areas such as ISO 13485:2016, ISO 14971:2019, FDA QSR, and the EU-MDR. Be careful with FDA QSR because it is about to change.

    On a personal note, consider the role of the hiring manager. I would divide the resumes into two piles. Professional certifications went into the "maybe" pile. Without professional certifications went into the "probably not" pile. Degrees without certifications went into the "probably not" pile. Professional certificates combine knowledge and experience, while degrees don't necessarily include experience. (Book smart – street stupid)



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 4.  RE: Is there any certification that can be advantageous for my career and positively impact my resume?

    Posted 17-Aug-2023 19:15

    For someone wanting to shift into Regulatory CMC from a biotech bench scientist CMC role of 7+ years, would you recommend going all in on the certification first or trying to get the RA CMC job experience first? I think my skills in dossier preparation and functional understanding of the analytical data sets is highly transferrable and my work in analytical development afforded me the attention to detail and organization skills to excel in the role but it's hard to know what a hiring manager would consider attractive attributes on a CV in order to make it to the successful resume pile to achieve that career shift.



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    Kiriaki Ignatiadis
    Woburn MA
    United States
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  • 5.  RE: Is there any certification that can be advantageous for my career and positively impact my resume?

    This message was posted by a user wishing to remain anonymous
    Posted 30 days ago
    This message was posted by a user wishing to remain anonymous

    Hello Anon,

    I'd recommend RAPS RAC certification.

    Thanks 




  • 6.  RE: Is there any certification that can be advantageous for my career and positively impact my resume?

    Posted 30 days ago

    There are lots of certificates offered by Temple University as well.........



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    Karen Zimm RAC
    Associate Director CMC - Global Regulatory Affairs
    Johnson & Johnson Family of Companies - ENTERPRISE
    Stockton NJ
    United States
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