Regulatory Open Forum

 View Only
  • 1.  Looking for regulatory consultant with class I consumer product experience

    Posted 10-Oct-2018 18:20

    Hi RAPS community, 

    Our start up in the Bay Area is looking for a regulatory consultant with experience in class I direct to consumer products. Experience in the dental space preferable. 

    If you're interested, please reach out!



    ------------------------------
    Kristina Cook
    San Francisco CA
    United States
    ------------------------------


  • 2.  RE: Looking for regulatory consultant with class I consumer product experience

    Posted 11-Oct-2018 04:17
      |   view attached
    Hi Kristina, 

    I have a quality background with experience in orthopeadics and cancer research equipment. In addition AED equipment. Well, I would really like to launch my career in RA and just need an opportunity to come in and learn all I can. I am from an engineering background in quality and very eager to learn and grow in RA. I have attached my CV and feel free to reach out to me. 


    Thanks







    ------------------------------
    Mike Ayeni, MBA, Six Sigma GB
    Raleigh, NC

    ------------------------------

    Attachment(s)

    docx
    Asceptic Res.docx   29 KB 1 version


  • 3.  RE: Looking for regulatory consultant with class I consumer product experience

    Posted 11-Oct-2018 11:54
    Hi Kristina, 

    I am a regulatory consultant and have been in regulatory affairs for 22 years.  I would be more than happy to help you out with your direct to consumer products.  Please feel free to contact me directly at regsolutionsmc@gmail.com if you would like to discuss further.  

    Best regards, 
    Melissa

    ------------------------------
    Melissa Clark
    Clark Regulatory Solutions, LLC

    ------------------------------



  • 4.  RE: Looking for regulatory consultant with class I consumer product experience

    Posted 11-Oct-2018 13:59
    Hi Kristina,

    I represent Fang Consulting and believe we would be able to assist you.

    Fang Consulting, Ltd. is a team of 46 principal, senior and junior regulatory affairs and quality assurance consultants who have experience with Class I, II, and III medical devices.  We are headquartered in Minneapolis, MN with offices in Austin, TX and Denver, CO and provide remote, as well as on-site support.  We will gladly provide more detail about our experience and would appreciate the opportunity to speak with you about how we can best support you and your team.

    Please feel free to visit our website (https://fangconsulting.com/) to learn more about us or reach directly to myself (Frank@fangconsulting.com) or our Director of Business Management, Stacey Stein (stacey@fangconsulting.com).

    Best Regards,
    Frank

    ------------------------------
    Frank Maistrovich
    Minneapolis MN
    United States
    ------------------------------



  • 5.  RE: Looking for regulatory consultant with class I consumer product experience

    Posted 12-Oct-2018 02:09
    Kristina hI
    Kristuna hi, Yes. We can definatly be of assistance. we had been servicing the dental industry for two decades and we provide product compliance and registartion consultation on a global scale through a dedicated medtech regulatory tool.

    LICENSALE Global Medtech registration system can handle any type of product registration in 125 counties around the world allowing you to generate and register your product faster and save 50% of your overall product registration costs in any market. it's been rapidly adopted by the MedTech industry and had processed more than 4000 products submission since 2013. it is by far the most advanced product registration. The technology available for Medtech Regulatory Affairs professional. the company behind this products is the e Arazy Group, a multi-facet medical and IVD device consulting company with 22-years experience and offices 65 different markets around the world including US and EU. Learn more at 
    Global MedTech Device Registration
    Licensale remove preview
    Global MedTech Device Registration
    View this on Licensale >

    contact me please at info@licensale.com to set up a demo.

    ------------------------------
    Benjamin Arazy
    President and C.E.O
    Vancouver BC
    Canada
    ------------------------------



  • 6.  RE: Looking for regulatory consultant with class I consumer product experience

    Posted 12-Oct-2018 07:57

    Hi, Kristina - 
    The firm I work for, R&Q Solutions, can definitely help with your situation.  We have a number of professionals with experience with dental devices.  Please reach out to Matt Burger (contact info below) if you'd like to get move information.

    Matthew Burger

    Account Director

    R&Q…the and means more

    Office:  1-877-961-0982

    Cell:  724-961-0982

    mburger@rqteam.com

    http://www.rqteam.com



    ------------------------------
    John Haney, MSLBE, CBA
    Operations Manager, Philadelphia Territory
    R&Q Solutions
    www.rqteam.com
    ------------------------------



  • 7.  RE: Looking for regulatory consultant with class I consumer product experience

    Posted 12-Oct-2018 10:46
    Hi Kristina,

    ProMedic, LLC has over 25 years experience with Class I and Class II devices including several dental devices.  I am confident we would be able to assist you.

    Kind regards,
    Nichole

    ------------------------------
    Nichole Leahy-Glass
    Director, RA/QA Consulting
    Noblesville IN
    United States
    ------------------------------