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Which RAPS online courses should I take to gain knowledge on U.S device regulations?

  • 1.  Which RAPS online courses should I take to gain knowledge on U.S device regulations?

    Posted 09-Apr-2017 22:11
    Hello everyone!

    I want to gain knowledge on U.S Medical Device regulations and product registration requirements to get a job in the U.S market. I presently have over 5 years of reg experience in Singapore and Asia pacific.

    I have completed the 'Medical devices: U.S regulations' course from RAPS online library which covered QSRs, Risk management, Advertising, postmarket, labeling etc briefly.

    Can you please suggest, based on your U.S industry experience which other RAPS courses or any other univ/ certification courses can help me become more relevant to the Job market here?

    Below are the RAPS courses to choose from
    - FDA Law and regulation
    -Medical Devices: Postmarket Surveillance
    - Medical Devices: Risk Management
    - Medical Devices: Corrections, Removals and Directed Recalls
    - Project Management for Regulatory Professionals
    - Regulatory Due Diligence for Product Development
    - Regulation of IVDs in the US

    Thanks a lot for your time! :)


    ------------------------------
    Pooja Mhambrey
    Foster City CA
    United States
    ------------------------------


  • 2.  RE: Which RAPS online courses should I take to gain knowledge on U.S device regulations?

    Posted 10-Apr-2017 12:29

    Hi Pooja,

    Here are some references that may be of interest to you:

    • The US RAC exam.  This exam will require you to study the US regulatory market across various industries, e.g. pharmaceuticals, medical devices, and demonstrate your understanding.  After you pass the exam, you will be able to reference the certification for potential employers.
      About the RAC | RAPS
    • FDA has an online learning portal which contains a ton of information, including FDA background and information on specific product types, e.g. pharmaceuticals, medical devices.  FDA Learning Portal for Students, Academia, and Industry
    • There are regulatory programs offered by various universities, ranging from certificate programs to masters programs.  One example is the UCI Extension certification program.  Regulatory Affairs and Compliance
    I hope that this gives you a good starting place!

    Liz

    ------------------------------
    Elizabeth Goldstein RAC
    Regulatory Affairs Specialist
    Medtronic Vascular
    Santa Rosa CA
    United States
    ------------------------------

    Original Message


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